The Effect of Exercise Training on Mental Stress-Induced Silent Ischemia

Status Completed

Clinical 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. 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.

Clinical Trial 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: Randomized

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00018252
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	N/A
Start date	April 1997
Completion date	March 2000

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.