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

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018252
• Other study ID #: AGCG-003-96F
• Status: Completed
• Phase: N/A
• First received: July 3, 2001
• Last updated: January 20, 2009
• Start date: April 1997
• Est. completion date: March 2000

Study information

• Verified date: June 2001
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older
• Eligibility: Older individuals without a history of overt CAD.

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Stress, Psychological

Intervention

Behavioral:
• exercise

Locations

Country	Name	City	State
United States	VA Maryland Health Care System	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,