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Cardiovascular Effects of Sporting Events

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795405
First Posted: November 21, 2008
Last Update Posted: August 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
China National Center for Cardiovascular Diseases
Information provided by:
Chinese Academy of Medical Sciences, Fuwai Hospital
  Purpose
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.

Condition Intervention Phase
Coronary Heart Disease Behavioral: Exposure to sporting events Behavioral: No exposure to sporting events Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cardiovascular Effects of Major Sporting Events in Subjects With Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences, Fuwai Hospital:

Primary Outcome Measures:
  • Evidence of definite myocardial ischemia confirmed by Holter monitoring [ Time Frame: 2 months ]
  • Blood pressure measured by ambulatory blood pressure monitoring [ Time Frame: 2 months ]
  • Heart rate variability [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Episode of angina [ Time Frame: 3 months ]
  • Episode of neurological events [ Time Frame: 3 months ]
  • Episode of arrhythmia [ Time Frame: 3 months ]

Enrollment: 38
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1
No exposure to sporting events
Behavioral: No exposure to sporting events
No exposure to sporting events
Experimental: 2
Exposure to sporting events
Behavioral: Exposure to sporting events
Exposure to sporting events

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795405


Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
China National Center for Cardiovascular Diseases
Investigators
Principal Investigator: Shengshou Hu, MD Cardiovascular Institue and Fuwai Hospital
  More Information

Responsible Party: Shengshou Hu / President, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT00795405     History of Changes
Other Study ID Numbers: sporting events
First Submitted: November 20, 2008
First Posted: November 21, 2008
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by Chinese Academy of Medical Sciences, Fuwai Hospital:
sporting events
stress
myocardial ischemia
ST-segment depression
blood pressure

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases