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1. Short-term exposure to ambient air pollution and individual emergency department visits for COVID-19:a case-crossover study in Canada

Author

Lavigne, E. (Eric), Ryti, N. (Niilo), Gasparrini, A. (Antonio), Sera, F. (Francesco), Weichenthal, S. (Scott), Chen, H. (Hong), To, T. (Teresa), Evans, G. J. (Greg J), Sun, L. (Liu), Dheri, A. (Aman), Lemogo, L. (Lionnel), Kotchi, S. O. (Serge Olivier), Stieb, D. (Dave), Lavigne, E. (Eric), Ryti, N. (Niilo), Gasparrini, A. (Antonio), Sera, F. (Francesco), Weichenthal, S. (Scott), Chen, H. (Hong), To, T. (Teresa), Evans, G. J. (Greg J), Sun, L. (Liu), Dheri, A. (Aman), Lemogo, L. (Lionnel), Kotchi, S. O. (Serge Olivier), and Stieb, D. (Dave)

Abstract

Background: Ambient air pollution is thought to contribute to increased risk of COVID-19, but the evidence is controversial. Objective: To evaluate the associations between short-term variations in outdoor concentrations of ambient air pollution and COVID-19 emergency department (ED) visits. Methods: We conducted a case-crossover study of 78 255 COVID-19 ED visits in Alberta and Ontario, Canada between 1 March 2020 and 31 March 2021. Daily air pollution data (ie, fine particulate matter with diameter less than 2.5 µm (PM2.5), nitrogen dioxide (NO₂) and ozone were assigned to individual case of COVID-19 in 10 km × 10 km grid resolution. Conditional logistic regression was used to estimate associations between air pollution and ED visits for COVID-19. Results: Cumulative ambient exposure over 0–3 days to PM2.5 (OR 1.010; 95% CI 1.004 to 1.015, per 6.2 µg/m³) and NO₂ (OR 1.021; 95% CI 1.015 to 1.028, per 7.7 ppb) concentrations were associated with ED visits for COVID-19. We found that the association between PM2.5 and COVID-19 ED visits was stronger among those hospitalised following an ED visit, as a measure of disease severity, (OR 1.023; 95% CI 1.015 to 1.031) compared with those not hospitalised (OR 0.992; 95% CI 0.980 to 1.004) (p value for effect modification=0.04). Conclusions: We found associations between short-term exposure to ambient air pollutants and COVID-19 ED visits. Exposure to air pollution may also lead to more severe COVID-19 disease.

Published
2023

2. Rapid increase in the risk of heat-related mortality

Author

Lüthi, S. (Samuel), Fairless, C. (Christopher), Fischer, E. M. (Erich M.), Scovronick, N. (Noah), Armstrong, B. (Ben), De Sousa Zanotti Stagliorio Coelho, M. (Micheline), Guo, Y. L. (Yue Leon), Guo, Y. (Yuming), Honda, Y. (Yasushi), Huber, V. (Veronika), Kyselý, J. (Jan), Lavigne, E. (Eric), Royé, D. (Dominic), Ryti, N. (Niilo), Silva, S. (Susana), Urban, A. (Aleš), Gasparrini, A. (Antonio), Bresch, D. N. (David N.), Vicedo-Cabrera, A. M. (Ana M.), Lüthi, S. (Samuel), Fairless, C. (Christopher), Fischer, E. M. (Erich M.), Scovronick, N. (Noah), Armstrong, B. (Ben), De Sousa Zanotti Stagliorio Coelho, M. (Micheline), Guo, Y. L. (Yue Leon), Guo, Y. (Yuming), Honda, Y. (Yasushi), Huber, V. (Veronika), Kyselý, J. (Jan), Lavigne, E. (Eric), Royé, D. (Dominic), Ryti, N. (Niilo), Silva, S. (Susana), Urban, A. (Aleš), Gasparrini, A. (Antonio), Bresch, D. N. (David N.), and Vicedo-Cabrera, A. M. (Ana M.)

Abstract

Heat-related mortality has been identified as one of the key climate extremes posing a risk to human health. Current research focuses largely on how heat mortality increases with mean global temperature rise, but it is unclear how much climate change will increase the frequency and severity of extreme summer seasons with high impact on human health. In this probabilistic analysis, we combined empirical heat-mortality relationships for 748 locations from 47 countries with climate model large ensemble data to identify probable past and future highly impactful summer seasons. Across most locations, heat mortality counts of a 1-in-100 year season in the climate of 2000 would be expected once every ten to twenty years in the climate of 2020. These return periods are projected to further shorten under warming levels of 1.5 °C and 2 °C, where heat-mortality extremes of the past climate will eventually become commonplace if no adaptation occurs. Our findings highlight the urgent need for strong mitigation and adaptation to reduce impacts on human lives.

Published
2023

3. Global, regional, and national burden of mortality associated with short-term temperature variability from 2000–19:a three-stage modelling study

Author

Wu, Y. (Yao), Li, S. (Shanshan), Zhao, Q. (Qi), Wen, B. (Bo), Gasparrini, A. (Antonio), Tong, S. (Shilu), Overcenco, A. (Ala), Urban, A. (Ales), Schneider, A. (Alexandra), Entezari, A. (Alireza), Vicedo-Cabrera, A. M. (Ana Maria), Zanobetti, A. (Antonella), Analitis, A. (Antonis), Zeka, A. (Ariana), Tobias, A. (Aurelio), Nunes, B. (Baltazar), Alahmad, B. (Barrak), Armstrong, B. (Ben), Forsberg, B. (Bertil), Pan, S.-C. (Shih-Chun), Iniguez, C. (Carmen), Ameling, C. (Caroline), De la Cruz Valencia, C. (Cesar), Astrom, C. (Christofer), Houthuijs, D. (Danny), Roye, D. (Dominic), Indermitte, E. (Ene), Lavigne, E. (Eric), Mayvaneh, F. (Fatemeh), Acquaotta, F. (Fiorella), De'Donato, F. (Francesca), Rao, S. (Shilpa), Sera, F. (Francesco), Carrasco-Escobar, G. (Gabriel), Kan, H. (Haidong), Orru, H. (Hans), Kim, H. (Ho), Holobaca, I.-H. (Iulian-Horia), Kysely, J. (Jan), Madureira, J. (Joana), Schwartz, J. (Joel), Jaakkola, J. J. (Jouni J. K.), Katsouyanni, K. (Klea), Diaz, M. H. (Magali Hurtado), Ragettli, M. S. (Martina S.), Hashizume, M. (Masahiro), Pascal, M. (Mathilde), Zanotti Stagliorio Coelho, M. d. (Micheline de Sousa), Ortega, N. V. (Nicolas Valdes), Ryti, N. (Niilo), Scovronick, N. (Noah), Michelozzi, P. (Paola), Correa, P. M. (Patricia Matus), Goodman, P. (Patrick), Nascimento Saldiva, P. H. (Paulo Hilario), Abrutzky, R. (Rosana), Osorio, S. (Samuel), Colistro, V. (Valentina), Huber, V. (Veronika), Lee, W. (Whanhee), Seposo, X. (Xerxes), Honda, Y. (Yasushi), Guo, Y. L. (Yue Leon), Bell, M. L. (Michelle L.), Guo, Y. (Yuming), Wu, Y. (Yao), Li, S. (Shanshan), Zhao, Q. (Qi), Wen, B. (Bo), Gasparrini, A. (Antonio), Tong, S. (Shilu), Overcenco, A. (Ala), Urban, A. (Ales), Schneider, A. (Alexandra), Entezari, A. (Alireza), Vicedo-Cabrera, A. M. (Ana Maria), Zanobetti, A. (Antonella), Analitis, A. (Antonis), Zeka, A. (Ariana), Tobias, A. (Aurelio), Nunes, B. (Baltazar), Alahmad, B. (Barrak), Armstrong, B. (Ben), Forsberg, B. (Bertil), Pan, S.-C. (Shih-Chun), Iniguez, C. (Carmen), Ameling, C. (Caroline), De la Cruz Valencia, C. (Cesar), Astrom, C. (Christofer), Houthuijs, D. (Danny), Roye, D. (Dominic), Indermitte, E. (Ene), Lavigne, E. (Eric), Mayvaneh, F. (Fatemeh), Acquaotta, F. (Fiorella), De'Donato, F. (Francesca), Rao, S. (Shilpa), Sera, F. (Francesco), Carrasco-Escobar, G. (Gabriel), Kan, H. (Haidong), Orru, H. (Hans), Kim, H. (Ho), Holobaca, I.-H. (Iulian-Horia), Kysely, J. (Jan), Madureira, J. (Joana), Schwartz, J. (Joel), Jaakkola, J. J. (Jouni J. K.), Katsouyanni, K. (Klea), Diaz, M. H. (Magali Hurtado), Ragettli, M. S. (Martina S.), Hashizume, M. (Masahiro), Pascal, M. (Mathilde), Zanotti Stagliorio Coelho, M. d. (Micheline de Sousa), Ortega, N. V. (Nicolas Valdes), Ryti, N. (Niilo), Scovronick, N. (Noah), Michelozzi, P. (Paola), Correa, P. M. (Patricia Matus), Goodman, P. (Patrick), Nascimento Saldiva, P. H. (Paulo Hilario), Abrutzky, R. (Rosana), Osorio, S. (Samuel), Colistro, V. (Valentina), Huber, V. (Veronika), Lee, W. (Whanhee), Seposo, X. (Xerxes), Honda, Y. (Yasushi), Guo, Y. L. (Yue Leon), Bell, M. L. (Michelle L.), and Guo, Y. (Yuming)

Abstract

Background: Increased mortality risk is associated with short-term temperature variability: However, to our knowledge, there has been no comprehensive assessment of the temperature variability-related mortality burden worldwide. In this study, using data from the MCC Collaborative Research Network, we first explored the association between temperature variability and mortality across 43 countries or regions. Then, to provide a more comprehensive picture of the global burden of mortality associated with temperature variability, global gridded temperature data with a resolution of 0·5° × 0·5° were used to assess the temperature variability-related mortality burden at the global, regional, and national levels. Furthermore, temporal trends in temperature variability-related mortality burden were also explored from 2000–19. Methods: In this modelling study, we applied a three-stage meta-analytical approach to assess the global temperature variability-related mortality burden at a spatial resolution of 0·5° × 0·5° degrees from 2000–19. Temperature variability was calculated as the SD of the average of the same and previous days’ minimum and maximum temperatures. We first obtained location-specific temperature variability related-mortality associations based on a daily time series of 750 locations from the Multi-country Multi-city Collaborative Research Network. We subsequently constructed a multivariable meta-regression model with five predictors to estimate grid-specific temperature variability related-mortality associations across the globe. Finally, percentage excess in mortality and excess mortality rate were calculated to quantify the temperature variability-related mortality burden and to further explore its temporal trend over two decades. Findings: An increasing trend in temperature variability was identified at the global level from 2000 to 2019. Globally, 1753392 deaths (95% CI 1159 901–2357 718) were associated with temperature variability per year, ac

Published
2022

4. Short term associations of ambient nitrogen dioxide with daily total, cardiovascular, and respiratory mortality:multilocation analysis in 398 cities

Author

Meng, X. (Xia), Liu, C. (Cong), Chen, R. (Renjie), Sera, F. (Francesco), Vicedo-Cabrera, A. M. (Ana Maria), Milojevic, A. (Ai), Guo, Y. (Yuming), Tong, S. (Shilu), Coelho, M. d. (Micheline de Sousa Zanotti Stagliorio), Saldiva, P. H. (Paulo Hilario Nascimento), Lavigne, E. (Eric), Correa, P. M. (Patricia Matus), Ortega, N. V. (Nicolas Valdes), Garcia, S. O. (Samuel Osorio), Kysely, J. (Jan), Urban, A. (Ales), Orru, H. (Hans), Maasikmets, M. (Marek), Jaakkola, J. J. (Jouni J. K.), Ryti, N. (Niilo), Huber, V. (Veronika), Schneider, A. (Alexandra), Katsouyanni, K. (Klea), Analitis, A. (Antonis), Hashizume, M. (Masahiro), Honda, Y. (Yasushi), Ng, C. F. (Chris Fook Sheng), Nunes, B. (Baltazar), Teixeira, J. P. (Joao Paulo), Holobaca, I. H. (Iulian Horia), Fratianni, S. (Simona), Kim, H. (Ho), Tobias, A. (Aurelio), Iniguez, C. (Carmen), Forsberg, B. (Bertil), Astrom, C. (Christofer), Ragettli, M. S. (Martina S.), Guo, Y. L. (Yue-Liang Leon), Pan, S.-C. (Shih-Chun), Li, S. (Shanshan), Bell, M. L. (Michelle L.), Zanobetti, A. (Antonella), Schwartz, J. (Joel), Wu, T. (Tangchun), Gasparrini, A. (Antonio), and Kan, H. (Haidong)

Abstract

Objective: To evaluate the short term associations between nitrogen dioxide (NO₂) and total, cardiovascular, and respiratory mortality across multiple countries/regions worldwide, using a uniform analytical protocol. Design: Two stage, time series approach, with overdispersed generalised linear models and multilevel meta-analysis. Setting: 398 cities in 22 low to high income countries/regions. Main outcome measures: Daily deaths from total (62.8 million), cardiovascular (19.7 million), and respiratory (5.5 million) causes between 1973 and 2018. Results: On average, a 10 μg/m³ increase in NO₂ concentration on lag 1 day (previous day) was associated with 0.46% (95% confidence interval 0.36% to 0.57%), 0.37% (0.22% to 0.51%), and 0.47% (0.21% to 0.72%) increases in total, cardiovascular, and respiratory mortality, respectively. These associations remained robust after adjusting for co-pollutants (particulate matter with aerodynamic diameter ≤10 μm or ≤2.5 μm (PM₁₀ and PM2.5, respectively), ozone, sulfur dioxide, and carbon monoxide). The pooled concentration-response curves for all three causes were almost linear without discernible thresholds. The proportion of deaths attributable to NO₂ concentration above the counterfactual zero level was 1.23% (95% confidence interval 0.96% to 1.51%) across the 398 cities. Conclusions: This multilocation study provides key evidence on the independent and linear associations between short term exposure to NO₂ and increased risk of total, cardiovascular, and respiratory mortality, suggesting that health benefits would be achieved by tightening the guidelines and regulatory limits of NO₂.

Published
2021

5. Global, regional, and national burden of mortality associated with non-optimal ambient temperatures from 2000 to 2019:a three-stage modelling study

Author

Zhao, Q. (Qi), Guo, Y. (Yuming), Ye, T. (Tingting), Gasparrini, A. (Antonio), Tong, S. (Shilu), Overcenco, A. (Ala), Urban, A. (Ales), Schneider, A. (Alexandra), Entezari, A. (Alireza), Vicedo-Cabrera, A. M. (Ana Maria), Zanobetti, A. (Antonella), Analitis, A. (Antonis), Zeka, A. (Ariana), Tobias, A. (Aurelio), Nunes, B. (Baltazar), Alahmad, B. (Barrak), Armstrong, B. (Ben), Forsberg, B. (Bertil), Pan, S.-C. (Shih-Chun), iniguez, C. (Carmen), Ameling, C. (Caroline), De la Cruz Valencia, C. (Cesar), Astrom, C. (Christofer), Houthuijs, D. (Danny), Van Dung, D. (Do), Roye, D. (Dominic), Indermitte, E. (Ene), Lavigne, E. (Eric), Mayvaneh, F. (Fatemeh), Acquaotta, F. (Fiorella), de'Donato, F. (Francesca), Di Ruscio, F. (Francesco), Sera, F. (Francesco), Carrasco-Escobar, G. (Gabriel), Kan, H. (Haidong), Orru, H. (Hans), Kim, H. (Ho), Holobaca, I.-H. (Iulian-Horia), Kysely, J. (Jan), Madureira, J. (Joana), Schwartz, J. (Joel), Jaakkola, J. J. (Jouni J. K.), Katsouyanni, K. (Klea), Diaz, M. H. (Magali Hurtado), Ragettli, M. S. (Martina S.), Hashizume, M. (Masahiro), Pascal, M. (Mathilde), de Sousa Zanotti Stagliorio Coelho, M. (Micheline), Ortega, N. V. (Nicolas Valdes), Ryti, N. (Niilo), Scovronick, N. (Noah), Michelozzi, P. (Paola), Correa, P. M. (Patricia Matus), Goodman, P. (Patrick), Saldiva, P. H. (Paulo Hilario Nascimento), Abrutzky, R. (Rosana), Osorio, S. (Samuel), Rao, S. (Shilpa), Fratianni, S. (Simona), Dang, T. N. (Tran Ngoc), Colistro, V. (Valentina), Huber, V. (Veronika), Lee, W. (Whanhee), Seposo, X. (Xerxes), Honda, Y. (Yasushi), Guo, Y. L. (Yue Leon), Bell, M. L. (Michelle L.), Li, S. (Shanshan), Zhao, Q. (Qi), Guo, Y. (Yuming), Ye, T. (Tingting), Gasparrini, A. (Antonio), Tong, S. (Shilu), Overcenco, A. (Ala), Urban, A. (Ales), Schneider, A. (Alexandra), Entezari, A. (Alireza), Vicedo-Cabrera, A. M. (Ana Maria), Zanobetti, A. (Antonella), Analitis, A. (Antonis), Zeka, A. (Ariana), Tobias, A. (Aurelio), Nunes, B. (Baltazar), Alahmad, B. (Barrak), Armstrong, B. (Ben), Forsberg, B. (Bertil), Pan, S.-C. (Shih-Chun), iniguez, C. (Carmen), Ameling, C. (Caroline), De la Cruz Valencia, C. (Cesar), Astrom, C. (Christofer), Houthuijs, D. (Danny), Van Dung, D. (Do), Roye, D. (Dominic), Indermitte, E. (Ene), Lavigne, E. (Eric), Mayvaneh, F. (Fatemeh), Acquaotta, F. (Fiorella), de'Donato, F. (Francesca), Di Ruscio, F. (Francesco), Sera, F. (Francesco), Carrasco-Escobar, G. (Gabriel), Kan, H. (Haidong), Orru, H. (Hans), Kim, H. (Ho), Holobaca, I.-H. (Iulian-Horia), Kysely, J. (Jan), Madureira, J. (Joana), Schwartz, J. (Joel), Jaakkola, J. J. (Jouni J. K.), Katsouyanni, K. (Klea), Diaz, M. H. (Magali Hurtado), Ragettli, M. S. (Martina S.), Hashizume, M. (Masahiro), Pascal, M. (Mathilde), de Sousa Zanotti Stagliorio Coelho, M. (Micheline), Ortega, N. V. (Nicolas Valdes), Ryti, N. (Niilo), Scovronick, N. (Noah), Michelozzi, P. (Paola), Correa, P. M. (Patricia Matus), Goodman, P. (Patrick), Saldiva, P. H. (Paulo Hilario Nascimento), Abrutzky, R. (Rosana), Osorio, S. (Samuel), Rao, S. (Shilpa), Fratianni, S. (Simona), Dang, T. N. (Tran Ngoc), Colistro, V. (Valentina), Huber, V. (Veronika), Lee, W. (Whanhee), Seposo, X. (Xerxes), Honda, Y. (Yasushi), Guo, Y. L. (Yue Leon), Bell, M. L. (Michelle L.), and Li, S. (Shanshan)

Abstract

Background: Exposure to cold or hot temperatures is associated with premature deaths. We aimed to evaluate the global, regional, and national mortality burden associated with non-optimal ambient temperatures. Methods: In this modelling study, we collected time-series data on mortality and ambient temperatures from 750 locations in 43 countries and five meta-predictors at a grid size of 0·5° × 0·5° across the globe. A three-stage analysis strategy was used. First, the temperature–mortality association was fitted for each location by use of a time-series regression. Second, a multivariate meta-regression model was built between location-specific estimates and meta-predictors. Finally, the grid-specific temperature–mortality association between 2000 and 2019 was predicted by use of the fitted meta-regression and the grid-specific meta-predictors. Excess deaths due to non-optimal temperatures, the ratio between annual excess deaths and all deaths of a year (the excess death ratio), and the death rate per 100 000 residents were then calculated for each grid across the world. Grids were divided according to regional groupings of the UN Statistics Division. Findings: Globally, 5 083 173 deaths (95% empirical CI [eCI] 4 087 967–5 965 520) were associated with non-optimal temperatures per year, accounting for 9·43% (95% eCI 7·58–11·07) of all deaths (8·52% [6·19–10·47] were cold-related and 0·91% [0·56–1·36] were heat-related). There were 74 temperature-related excess deaths per 100 000 residents (95% eCI 60–87). The mortality burden varied geographically. Of all excess deaths, 2 617 322 (51·49%) occurred in Asia. Eastern Europe had the highest heat-related excess death rate and Sub-Saharan Africa had the highest cold-related excess death rate. From 2000–03 to 2016–19, the global cold-related excess death ratio changed by −0·51 percentage points (95% eCI −0·61 to −0·42) and the global heat-related excess death ratio increased by 0·21 percentage points (0·13–0·31), l

Published
2021

6. Central aortic hemodynamics following acute lower and upper-body exercise in a cold environment among patients with coronary artery disease

Author

Hintsala, H. E. (Heidi E.), Valtonen, R. I. (Rasmus I. P.), Kiviniemi, A. (Antti), Crandall, C. (Craig), Perkiömäki, J. (Juha), Hautala, A. (Arto), Mäntysaari, M. (Matti), Alén, M. (Markku), Ryti, N. (Niilo), Jaakkola, J. J. (Jouni J. K.), Ikäheimo, T. M. (Tiina M.), Hintsala, H. E. (Heidi E.), Valtonen, R. I. (Rasmus I. P.), Kiviniemi, A. (Antti), Crandall, C. (Craig), Perkiömäki, J. (Juha), Hautala, A. (Arto), Mäntysaari, M. (Matti), Alén, M. (Markku), Ryti, N. (Niilo), Jaakkola, J. J. (Jouni J. K.), and Ikäheimo, T. M. (Tiina M.)

Abstract

Exercise is beneficial to cardiovascular health, evidenced by reduced post-exercise central aortic blood pressure (BP) and wave reflection. We assessed if post-exercise central hemodynamics are modified due to an altered thermal state related to exercise in the cold in patients with coronary artery disease (CAD). CAD patients (n = 11) performed moderate-intensity lower-body exercise (walking at 65–70% of HRmax) and rested in neutral (+ 22 °C) and cold (− 15 °C) conditions. In another protocol, CAD patients (n = 15) performed static (five 1.5 min work cycles, 10—30% of maximal voluntary contraction) and dynamic (three 5 min workloads, 56–80% of HRmax) upper-body exercise at the same temperatures. Both datasets consisted of four 30-min exposures administered in random order. Central aortic BP and augmentation index (AI) were noninvasively assessed via pulse wave analyses prior to and 25 min after these interventions. Lower-body dynamic exercise decreased post-exercise central systolic BP (6–10 mmHg, p < 0.001) and AI (1–6%, p < 0.001) both after cold and neutral and conditions. Dynamic upper-body exercise lowered central systolic BP (2–4 mmHg, p < 0.001) after exposure to both temperatures. In contrast, static upper-body exercise increased central systolic BP after exposure to cold (7 ± 6 mmHg, p < 0.001). Acute dynamic lower and upper-body exercise mainly lowers post-exercise central BP in CAD patients irrespective of the environmental temperature. In contrast, central systolic BP was elevated after static exercise in cold. CAD patients likely benefit from year-round dynamic exercise, but hemodynamic responses following static exercise in a cold environment should be examined further.

Published
2021

7. Good safety practice in a randomized controlled trial (CadColdEx) involving increased cardiac workload in patients with coronary artery disease

Author

Ikäheimo, T. M. (Tiina M.), Länsitie, M. (Miia), Valtonen, R. (Rasmus), Hintsala, H. E. (Heidi E.), Ryti, N. (Niilo), Perkiömäki, J. (Juha), Mäntysaari, M. (Matti), Hautala, A. J. (Arto J.), and Jaakkola, J. J. (Jouni J. K.)

Subjects
Controlled experiment, cold temperature, exercise, patient safety, coronary artery disease
Abstract

Background: Methodological information acknowledging safety of cardiac patients in controlled medical experiments are lacking. The descriptive report presents one good practice for considering safety in a randomized controlled study involving augmented cardiovascular strain among persons with coronary artery disease (CAD). Methods: The patients were pre-selected by a cardiologist according to strictly defined selection criteria. Further confirmation of eligibility included screening of health. In addition, assessments of physical capacity by a graded bicycle ergometer test were implemented and safety monitored by an exercise physiologist and medical doctor. In this context, an emergency simulation was also carried out. A total of 18 CAD patients each underwent four different experimental interventions where either temperature (+ 22 °C and − 15 °C) and the level of exercise (rest and brisk walking) were employed for 30 min in random order (72 experiments). Baseline (20 min) and follow-up (60 min) measurements were conducted resting at + 22 °C. ECG, and brachial blood pressure were measured and perceived exertion and symptoms of chest pain inquired throughout the experiments. An emergency nurse was responsible for the health monitoring and at least two persons followed the patient throughout the experiment. A medical doctor was available on call for consultation. The termination criteria followed the generally accepted international guidelines for exercise testing and were planned prior to the experiments. Results: The exercise test simulation revealed risks requiring changes in the study design and emergency response. The cardiovascular responses of the controlled trials were related to irregular HR, ST-depression or post-exercise hypotension. These were expected and the majority could be dealt on site by the research personnel and on call consultation. Only one patient was encouraged to seek for external health care consultation. Conclusions: Appropriate prospective design is a key to safe implementation of controlled studies involving cardiac patients and stimulation of cardiovascular function. This includes careful selection of participants, sufficient and knowledgeable staff, as well as identifying possible emergency situations and the required responses. Trial registration: ClinicalTrials ID: NCT02855905.

Published
2019

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