Cardiovascular Effects of Sporting Events

Coronary Heart Disease Clinical Trial

Official title:

Cardiovascular Effects of Major Sporting Events in Subjects With Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795405
• Other study ID #: sporting events
• Status: Completed
• Phase: Phase 0
• First received: November 20, 2008
• Last updated: August 4, 2009
• Start date: August 2008
• Est. completion date: October 2008

Study information

• Verified date: August 2009
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Major sporting events may have adverse cardiovascular effects in subjects with coronary heart disease. We also hypothesized that the adverse cardiovascular effects of sporting events are a result of psychobiological processes including stress-induced hemodynamic changes, autonomic dysfunction and parasympathetic withdrawal, and inflammatory and prothrombotic responses, all of which may in turn promote myocardial ischemia.

Description:

Observational studies suggest that exposure to sporting events may worsen symptoms of angina and trigger acute myocardial infarction. The mechanisms for this association are unknown. To date, there have been no controlled exposures in patients with coronary heart disease: an important population who may be particularly susceptible to the adverse cardiovascular effects of sporting events.

In a randomized crossover controlled study, 38 patients with prior myocardial infarction will be exposed to sporting events or not. Myocardial ischemia will be quantified by ST-segment analysis using continuous 12-lead electrocardiography, and blood pressure change will be analyzed using ambulatory blood pressure monitoring. Autonomic function will be assessed by heart rate variability. Ischemic, inflammatory and prothrombotic markers will also be measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Previous myocardial infarction (>6 months previously)treated by coronary revascularization

• On standard secondary preventative therapy

Exclusion Criteria:

• Angina pectoris (Canadian Cardiovascular Society grade =2)

• History of arrhythmia

• Uncontrolled hypertension

• Unstable coronary disease (acute coronary syndrome or unstable symptoms within 3 months)

• Occupational exposure to sporting events

• Diabetes

• Hepatic or renal failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Exposure to sporting events
Exposure to sporting events
• No exposure to sporting events
No exposure to sporting events

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	China National Center for Cardiovascular Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of definite myocardial ischemia confirmed by Holter monitoring		2 months	Yes
Primary	Blood pressure measured by ambulatory blood pressure monitoring		2 months	Yes
Primary	Heart rate variability		2 months	Yes
Secondary	Episode of angina		3 months	Yes
Secondary	Episode of neurological events		3 months	Yes
Secondary	Episode of arrhythmia		3 months	Yes