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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
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    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
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    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

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    Cardiovascular Effects of Sporting Events

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