The Effect of Exercise on Peripheral Blood Gene Expression in Angina

Not Applicable

Completed

• Conditions: Angina Pectoris
• Interventions: Behavioral: Structured exercise training

• Registration Number: NCT01147952
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Regular exercise is known to produce significant health benefits and to reduce the risk of heart diseases, although how this benefit occurs is not well understood. White blood cells are known to be involved in triggering heart attacks, and which genes are switched on or off in white blood cells determines whether they have beneficial or harmful effects. Previous studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood gene expression (which reflects white blood cell gene expression) is able to distinguish between patients with and without coronary artery disease, or patients who are able to develop good compared with poor coronary collateral arteries. Therefore, the gene expression signature in peripheral blood may provide novel diagnostic or prognostic information, and insight into the pathogenesis of heart disease.

We therefore hypothesise that exercise alters peripheral blood gene expression in patients with coronary artery disease and angina. This will identify possible ways that exercise improves angina and reduces the risk of heart disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-18
• Study First Submitted QC: 2010-06-18
• Study First Posted: 2010-06-22
• Study Start: 2010-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Class I to III angina pectoris (classified according to the Canadian Cardiovascular Society [CCS])with documented myocardial ischemia or coronary artery disease on angiography
• Ability to read and speak English to a level allowing satisfactory completion of written questionnaires and to understand instruction during the exercise programme.

Exclusion Criteria

• Acute coronary syndromes or recent myocardial infarction (<2 months)
• Left main coronary artery stenosis >25% or high-grade proximal left anterior descending artery stenosis
• Known reduced left ventricular function (ejection fraction <40%)
• Significant valvular heart disease
• Insulin-dependent diabetes mellitus
• Occupational, orthopedic, and other conditions that preclude regular exercise
• Patients whose ECG prevents interpretation of an exercise test (LBBB, RBBB, pacemaker implantation).
• Patients who already perform greater than 30min continuous exercise three times weekly (self-reported).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 week exercise training	Structured exercise training	-

Primary Outcome Measures

Name	Time	Method
Peripheral blood gene expression	24 weeks after starting 12 weeks exercise training programme
peripheral blood gene expression	12 weeks after exercise training (or conventional care)

Secondary Outcome Measures

Name	Time	Method
Depression Score	24wks after starting 12 week exercise programme (or conventional care)
Angina status	12wks after starting 12 week exercise programme (or conventional care)
Angina Status	24wks after starting 12 week exercise programme (or conventional care)
Anxiety Score	24wks after starting 12 week exercise programme (or conventional care)

Trial Locations

Locations (1)

NIHR Cardiovascular Biomedical Research Unit; 🇬🇧 Sheffield, South Yorkshire, United Kingdom