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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
History of Changes
  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
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (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:

U.S. FDA Resources

Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795405

Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
China National Center for Cardiovascular Diseases
Investigators
Principal Investigator: Shengshou Hu, MD Cardiovascular Institue and Fuwai Hospital
  More Information

No publications provided

Responsible Party: Shengshou Hu / President, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT00795405     History of Changes
Other Study ID Numbers: sporting events
Study First Received: November 20, 2008
Last Updated: August 4, 2009
Health Authority: China: Ministry of Health

Keywords provided by Cardiovascular Institute & Fuwai Hospital:
sporting events
stress
myocardial ischemia
ST-segment depression
blood pressure

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

ClinicalTrials.gov processed this record on June 17, 2013