Cardiovascular Effects of Sporting Events

NCT ID: NCT00795405

Last Updated: 2009-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

No exposure to sporting events

Group Type SHAM_COMPARATOR

No exposure to sporting events

Intervention Type BEHAVIORAL

No exposure to sporting events

2

Exposure to sporting events

Group Type EXPERIMENTAL

Exposure to sporting events

Intervention Type BEHAVIORAL

Exposure to sporting events

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exposure to sporting events

Exposure to sporting events

Intervention Type BEHAVIORAL

No exposure to sporting events

No exposure to sporting events

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cardiovascular Institute & Fuwai Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shengshou Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institue and Fuwai Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

sporting events

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.