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Completed

NCT Number: NCT00795405

Cardiovascular Effects of Sporting Events

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure to sporting events

Behavioral

Exposure to sporting events

No exposure to sporting events

Behavioral

No exposure to sporting events

Primary outcomes

  1. Evidence of definite myocardial ischemia confirmed by Holter monitoring

    Time frame: 2 months

  2. Blood pressure measured by ambulatory blood pressure monitoring

    Time frame: 2 months

  3. Heart rate variability

    Time frame: 2 months

Secondary outcomes

  1. Episode of angina

    Time frame: 3 months

  2. Episode of neurological events

    Time frame: 3 months

  3. Episode of arrhythmia

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Collaborators

  • China National Center for Cardiovascular Diseases

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 21, 2008
Registry last updated
Aug 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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