Coronary Heart DiseaseEarly Phase 1NCT00795405
Cardiovascular Effects of Sporting Events
A Early Phase 1 study testing Exposure to sporting events and No exposure to sporting events in people with Coronary Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Exposure to sporting events and No exposure to sporting events
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Oct 2008
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous myocardial infarction (>6 months previously)treated by coronary revascularization
- On standard secondary preventative therapy
Who cannot join
- 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
About this study
Official title: Cardiovascular Effects of Major Sporting Events in Subjects With Coronary Heart Disease
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.
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Exposure to sporting events, No exposure to sporting events
- Keywords
- sporting events, stress, myocardial ischemia, ST-segment depression, blood pressure
- Medical subject headings
- Coronary Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to sporting eventsBehavioural
Exposure to sporting events
No exposure to sporting eventsBehavioural
No exposure to sporting events
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | No exposure to sporting events Receives: Behavioral: No exposure to sporting events |
| 2 | Experimental | Exposure to sporting events Receives: Behavioral: Exposure to sporting events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of definite myocardial ischemia confirmed by Holter monitoring
Measured: 2 months
Blood pressure measured by ambulatory blood pressure monitoring
Measured: 2 months
Heart rate variability
Measured: 2 months
Secondary outcomes (3)
Episode of angina
Measured: 3 months
Episode of neurological events
Measured: 3 months
Episode of arrhythmia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- China National Center for Cardiovascular Diseases
- Investigators
- Shengshou Hu, MD, Principal investigator, Cardiovascular Institue and Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795405
- Sponsor's protocol ID
- sporting events
- Status last verified
- Aug 2009
- First submitted
- 20 Nov 2008
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Major Sporting Events in Subjects With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00795405
- Acronym / sponsor ID
- sporting events
- Conditions
- Coronary Heart Disease
- Keywords
- sporting events, stress, myocardial ischemia, ST-segment depression, blood pressure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- China National Center for Cardiovascular Diseases
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Behavioral: No exposure to sporting eventsNo exposure to sporting events |
| 2 | Experimental | Behavioral: Exposure to sporting eventsExposure to sporting events |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous myocardial infarction (>6 months previously)treated by coronary revascularization
- On standard secondary preventative therapy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to sporting eventsExposure to sporting events | Behavioural | 2 |
| No exposure to sporting eventsNo exposure to sporting events | Behavioural | 1 |
Primary outcome
Evidence of definite myocardial ischemia confirmed by Holter monitoring
Time frame: 2 months
Blood pressure measured by ambulatory blood pressure monitoring
Time frame: 2 months
Heart rate variability
Time frame: 2 months
3 secondary outcomes
Episode of angina
Time frame: 3 months
Episode of neurological events
Time frame: 3 months
Episode of arrhythmia
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengshou Hu, MD principal investigator
Cardiovascular Institue and Fuwai Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exposure to sporting events and No exposure to sporting events in people with Coronary Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of definite myocardial ischemia confirmed by Holter monitoring (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.