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Cardiovascular Effects of Sporting Events

This study has been completed.
Sponsor:
Collaborator:
China National Center for Cardiovascular Diseases
Information provided by:
Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT00795405
First received: November 20, 2008
Last updated: August 4, 2009
Last verified: August 2009

November 20, 2008
August 4, 2009
August 2008
October 2008   (final data collection date for primary outcome measure)
  • Evidence of definite myocardial ischemia confirmed by Holter monitoring [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Blood pressure measured by ambulatory blood pressure monitoring [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Heart rate variability [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00795405 on ClinicalTrials.gov Archive Site
  • Episode of angina [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Episode of neurological events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Episode of arrhythmia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cardiovascular Effects of Sporting Events
Cardiovascular Effects of Major Sporting Events in Subjects With Coronary Heart Disease

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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Coronary Heart Disease
  • Behavioral: Exposure to sporting events
    Exposure to sporting events
  • Behavioral: No exposure to sporting events
    No exposure to sporting events
  • Sham Comparator: 1
    No exposure to sporting events
    Intervention: Behavioral: No exposure to sporting events
  • Experimental: 2
    Exposure to sporting events
    Intervention: Behavioral: Exposure to sporting events
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00795405
sporting events
Yes
Shengshou Hu / President, Cardiovascular Institute & Fuwai Hospital
Cardiovascular Institute & Fuwai Hospital
China National Center for Cardiovascular Diseases
Principal Investigator: Shengshou Hu, MD Cardiovascular Institue and Fuwai Hospital
Cardiovascular Institute & Fuwai Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP