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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02913820
Other study ID # EK28-433ex15/16
Secondary ID
Status Completed
Phase N/A
First received September 22, 2016
Last updated January 9, 2018
Start date January 2007
Est. completion date June 30, 2017

Study information

Verified date January 2018
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Changes in the ambient temperature (esp. warm to cold) as well as exercise are triggers for vasospasms and plaque rupture. Weather data (temperature, precipitation in general as well as snowfall and changes in atmospheric pressure) will be correlated with the incidence of myocardial infarctions.


Description:

Besides classical cardiovascular risk factors such as smoking, obesity, elevated cholesterol levels and diabetes there are also acute factors potentially triggering acute coronary events. The impact of air temperature (changes) or humidity are of potential relevance. In addition, exercise and the associated increase in oxygen demand of the myocardium and blood pressure is another trigger for plaque rupture and the acute onset of myocardial infarction. Male patients as well as patients with previous coronary heart disease or little regular exercise are at increased risk.

Possible additional mechanisms of exercise induced myocardial infarction are vasospasm and changes in blood clotting.

Changes in the ambient temperature (warm to cold) can also induce vasospasm which might result in reduced perfusion and plaque rupture. It seems that male patients are more involved than female patients.

Taking the exercise and the ambient temperature changes into consideration, heavy snowfall with consecutive snow shoveling is an augmented risk for acute myocardial infarction.

The rationale of the study is to test if the above mentioned constellation of environmental factors as well as potential increased exercise have a significant and independent impact on the incidence of myocardial infarctions


Recruitment information / eligibility

Status Completed
Enrollment 18075
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- myocardial infarction being confirmed or treated in the cathlab

Exclusion Criteria:

Study Design


Intervention

Other:
snowfall > 5cm/day
the number of myocardial infarctions of every day analysed in this study will be correlated with the respective values of snowfall

Locations

Country Name City State
Austria Medical University of Graz Graz

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (10)

Burke AP, Farb A, Malcom GT, Liang Y, Smialek JE, Virmani R. Plaque rupture and sudden death related to exertion in men with coronary artery disease. JAMA. 1999 Mar 10;281(10):921-6. — View Citation

Chevalier L, Hajjar M, Douard H, Cherief A, Dindard JM, Sedze F, Ricard R, Vincent MP, Corneloup L, Gencel L, Carre F. Sports-related acute cardiovascular events in a general population: a French prospective study. Eur J Cardiovasc Prev Rehabil. 2009 Jun; — View Citation

Ciampricotti R, el Gamal MI, Bonnier JJ, Relik TH. Myocardial infarction and sudden death after sport: acute coronary angiographic findings. Cathet Cardiovasc Diagn. 1989 Aug;17(4):193-7. — View Citation

Giri S, Thompson PD, Kiernan FJ, Clive J, Fram DB, Mitchel JF, Hirst JA, McKay RG, Waters DD. Clinical and angiographic characteristics of exertion-related acute myocardial infarction. JAMA. 1999 Nov 10;282(18):1731-6. Erratum in: JAMA 1999 Dec 8;282(22): — View Citation

Gordon JB, Ganz P, Nabel EG, Fish RD, Zebede J, Mudge GH, Alexander RW, Selwyn AP. Atherosclerosis influences the vasomotor response of epicardial coronary arteries to exercise. J Clin Invest. 1989 Jun;83(6):1946-52. — View Citation

Janardhanan R, Henry Z, Hur DJ, Lin CM, Lopez D, Reagan PM, Rudnick SR, Koshko TJ, Keeley EC. The snow-shoveler's ST elevation myocardial infarction. Am J Cardiol. 2010 Aug 15;106(4):596-600. doi: 10.1016/j.amjcard.2010.03.075. — View Citation

Nitenberg A, Chemla D, Antony I. Epicardial coronary artery constriction to cold pressor test is predictive of cardiovascular events in hypertensive patients with angiographically normal coronary arteries and without other major coronary risk factor. Athe — View Citation

Thompson DR, Pohl JE, Tse YY, Hiorns RW. Meteorological factors and the time of onset of chest pain in acute myocardial infarction. Int J Biometeorol. 1996 Sep;39(3):116-20. — View Citation

van Teeffelen WM, de Beus MF, Mosterd A, Bots ML, Mosterd WL, Pool J, Doevendans PA, Grobbee DE. Risk factors for exercise-related acute cardiac events. A case-control study. Br J Sports Med. 2009 Sep;43(9):722-5. doi: 10.1136/bjsm.2009.057307. — View Citation

Willich SN, Lewis M, Löwel H, Arntz HR, Schubert F, Schröder R. Physical exertion as a trigger of acute myocardial infarction. Triggers and Mechanisms of Myocardial Infarction Study Group. N Engl J Med. 1993 Dec 2;329(23):1684-90. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary myocardial infarction the number of myocardial infarctions of every day analysed in this study will be correlated with the respective values of snowfall 1 day
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