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Clinical Trials/NCT01147952
NCT01147952
Completed
Not Applicable

A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina

Sheffield Teaching Hospitals NHS Foundation Trust1 site in 1 country60 target enrollmentNovember 2010
ConditionsAngina Pectoris

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Angina Pectoris
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Enrollment
60
Locations
1
Primary Endpoint
Peripheral blood gene expression
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
May 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Peripheral blood gene expression

Time Frame: 24 weeks after starting 12 weeks exercise training programme

peripheral blood gene expression

Time Frame: 12 weeks after exercise training (or conventional care)

Secondary Outcomes

  • 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))

Study Sites (1)

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