Myocardial IschemiaNCT00018252
The Effect of Exercise Training on Mental Stress-Induced Silent Ischemia
A study testing exercise in people with Myocardial Ischemia, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Coronary artery disease (CAD) remains the leading cause of death in the elderly. Silent myocardial ischemia (SI) is a manifestation of CAD in which there is a transient alteration in myocardial perfusion, function, and/or electrical activity not accompanied by chest pain. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 1997to Mar 2000
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Older individuals without a history of overt CAD.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Maryland Health Care System
Baltimore, Maryland, 21201
About this study
Coronary artery disease (CAD) remains the leading cause of death in the elderly. Silent myocardial ischemia (SI) is a manifestation of CAD in which there is a transient alteration in myocardial perfusion, function, and/or electrical activity not accompanied by chest pain. Mental and emotional stress, in particular hostility and anger are potent inducers of SI, Individuals with SI are at a 3-5 fold higher risk for the development of angina, myocardial infarction and death than subjects without SI.
Read the detailed description
The hypothesis of this study is that older individuals with occult cad, mental stress/ emotional arousal (anger) increases sympathetic nervous system activity resulting in vasoconstriction thereby eliciting transient episodes of SI. Therefore an aerobic exercise intervention that reduces the response to anger/hostility and improves vascular compliance will decrease the ischemic burden in SI patients. The specific objectives are: To determine if non-smoking older individuals with exercise-induced SI have increased vasoreactivity (blood pressure, heart rate) responses to the laboratory presentation of mental stressors, decreased vascular compliance and brachial artery endothelial reactivity compared to matched non-ischemic controls; 2) To perform a randomized clinical trial that will examine the effects of 9 months of aerobic exercise training versus usual care on vasoreactivity, vascular compliance and ischemic burden on Holter monitor. Older individuals without a history of overt CAD will be recruited and evaluated for the presence of exercise-induced SI. Baseline cross-sectional comparisons of vasoreactivity and cardiovascular function will be performed between those with SI and non-ischemic controls. The individuals with SI will be enrolled in a randomized clinical trial of exercise vs usual care. Exercise treadmill testing with measurement of maximal aerobic capacity will be used to determine fitness. Vasoactivity will be quantified during a mental stress test with real time 2d echo imaging. Vascular function will be assessed using high frequency ultrasound measurements of flow-mediated brachial artery endothelial reactivity.
- Conditions
- Myocardial Ischemia
- Being tested
- exercise
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startApr 1997
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- 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
- Phase N/A
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018252
- Sponsor's protocol ID
- AGCG-003-96F
- Status last verified
- Jun 2001
- First submitted
- 3 Jul 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Training on Mental Stress-Induced Silent Ischemia
- ClinicalTrials.gov ID
- NCT00018252
- Acronym / sponsor ID
- AGCG-003-96F
- Conditions
- Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 1997
- Study completion
- Mar 2000
- First posted
- 5 Jul 2001 (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.
Coronary artery disease (CAD) remains the leading cause of death in the elderly. Silent myocardial ischemia (SI) is a manifestation of CAD in which there is a transient alteration in myocardial perfusion, function, and/or electrical activity not accompanied by chest pain. Mental and emotional stress, in particular hostility and anger are potent inducers of SI, Individuals with SI are at a 3-5 fold higher risk for the development of angina, myocardial infarction and death than subjects without SI.
Detailed description
The hypothesis of this study is that older individuals with occult cad, mental stress/ emotional arousal (anger) increases sympathetic nervous system activity resulting in vasoconstriction thereby eliciting transient episodes of SI. Therefore an aerobic exercise intervention that reduces the response to anger/hostility and improves vascular compliance will decrease the ischemic burden in SI patients. The specific objectives are: To determine if non-smoking older individuals with exercise-induced SI have increased vasoreactivity (blood pressure, heart rate) responses to the laboratory presentation of mental stressors, decreased vascular compliance and brachial artery endothelial reactivity compared to matched non-ischemic controls; 2) To perform a randomized clinical trial that will examine the effects of 9 months of aerobic exercise training versus usual care on vasoreactivity, vascular compliance and ischemic burden on Holter monitor. Older individuals without a history of overt CAD will be recruited and evaluated for the presence of exercise-induced SI. Baseline cross-sectional comparisons of vasoreactivity and cardiovascular function will be performed between those with SI and non-ischemic controls. The individuals with SI will be enrolled in a randomized clinical trial of exercise vs usual care. Exercise treadmill testing with measurement of maximal aerobic capacity will be used to determine fitness. Vasoactivity will be quantified during a mental stress test with real time 2d echo imaging. Vascular function will be assessed using high frequency ultrasound measurements of flow-mediated brachial artery endothelial reactivity.
Study design
- Allocation
- Randomised
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| exercise | Behavioural | – |
Primary outcome
Not reported in the source record.
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 21 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Myocardial Ischemia, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
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 21 Jan 2009.