Cardiovascular Effects of Sporting Events
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Exposure to sporting events
No exposure to sporting events
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Heart Disease focused on measuring sporting events, stress, myocardial ischemia, ST-segment depression, blood pressure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
1
2
Arm Description
No exposure to sporting events
Exposure to sporting events
Outcomes
Primary Outcome Measures
Evidence of definite myocardial ischemia confirmed by Holter monitoring
Blood pressure measured by ambulatory blood pressure monitoring
Heart rate variability
Secondary Outcome Measures
Episode of angina
Episode of neurological events
Episode of arrhythmia
Full Information
NCT ID
NCT00795405
First Posted
November 20, 2008
Last Updated
August 4, 2009
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT00795405
Brief Title
Cardiovascular Effects of Sporting Events
Official Title
Cardiovascular Effects of Major Sporting Events in Subjects With Coronary Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators
China National Center for Cardiovascular Diseases
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
sporting events, stress, myocardial ischemia, ST-segment depression, blood pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Sham Comparator
Arm Description
No exposure to sporting events
Arm Title
2
Arm Type
Experimental
Arm Description
Exposure to sporting events
Intervention Type
Behavioral
Intervention Name(s)
Exposure to sporting events
Intervention Description
Exposure to sporting events
Intervention Type
Behavioral
Intervention Name(s)
No exposure to sporting events
Intervention Description
No exposure to sporting events
Primary Outcome Measure Information:
Title
Evidence of definite myocardial ischemia confirmed by Holter monitoring
Time Frame
2 months
Title
Blood pressure measured by ambulatory blood pressure monitoring
Time Frame
2 months
Title
Heart rate variability
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Episode of angina
Time Frame
3 months
Title
Episode of neurological events
Time Frame
3 months
Title
Episode of arrhythmia
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengshou Hu, MD
Organizational Affiliation
Cardiovascular Institue and Fuwai Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Cardiovascular Effects of Sporting Events
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