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| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 3, 2001 |
| Last Updated Date | January 20, 2009 |
| Start Date ICMJE | April 1997 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00018252 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | The Effect of Exercise Training on Mental Stress-Induced Silent Ischemia |
| Official Title ICMJE | The Effect of Exercise Training on Mental Stress-Induced Silent Ischemia |
| Brief 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. |
| 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 Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Randomized |
| Condition ICMJE | Myocardial Ischemia |
| Intervention ICMJE | Behavioral: exercise |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | March 2000 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Older individuals without a history of overt CAD. |
| Gender | Both |
| Ages | 60 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00018252 |
| Responsible Party | |
| Study ID Numbers ICMJE | AGCG-003-96F |
| Study Sponsor ICMJE | Department of Veterans Affairs |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Department of Veterans Affairs |
| Verification Date | June 2001 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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