NCT00795405

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2008

Shorter than P25 for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

2 months

First QC Date

November 20, 2008

Last Update Submit

August 4, 2009

Conditions

Coronary Heart Disease

Keywords

sporting eventsstressmyocardial ischemiaST-segment depressionblood pressure

Outcome Measures

Primary Outcomes (3)

  • Evidence of definite myocardial ischemia confirmed by Holter monitoring

    2 months

  • Blood pressure measured by ambulatory blood pressure monitoring

    2 months

  • Heart rate variability

    2 months

Secondary Outcomes (3)

  • Episode of angina

    3 months

  • Episode of neurological events

    3 months

  • Episode of arrhythmia

    3 months

Study Arms (2)

1

SHAM COMPARATOR

No exposure to sporting events

Behavioral: No exposure to sporting events

2

EXPERIMENTAL

Exposure to sporting events

Behavioral: Exposure to sporting events

Interventions

Exposure to sporting eventsBEHAVIORAL

Exposure to sporting events

2
No exposure to sporting eventsBEHAVIORAL

No exposure to sporting events

1

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous myocardial infarction (\>6 months previously)treated by coronary revascularization
  • On standard secondary preventative therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Shengshou Hu, MD

    Cardiovascular Institue and Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 21, 2008

Study Start

August 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

August 6, 2009

Record last verified: 2009-08