The Effect of Exercise on Peripheral Blood Gene Expression in Angina

Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147952
• Other study ID #: STH15565
• Status: Completed
• Phase: N/A
• First received: June 18, 2010
• Last updated: April 13, 2016
• Start date: November 2010
• Est. completion date: May 2014

Study information

• Verified date: April 2016
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

Behavioral:
• Structured exercise training
randomised to 12 weeks of exercise training up to three times weekly. Training will be interval training with active recovery, with 3 min intervals conducted 10bpm below angina threshold.

Locations

Country	Name	City	State
United Kingdom	NIHR Cardiovascular Biomedical Research Unit	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral blood gene expression		baseline	No
Primary	Peripheral blood gene expression		6wks after starting 12week exercise training (or conventional care)	No
Primary	peripheral blood gene expression		12 weeks after exercise training (or conventional care)	No
Primary	Peripheral blood gene expression		24 weeks after starting 12 weeks exercise training programme	No
Secondary	Angina status		baseline	No
Secondary	Angina status		6wks after starting 12 week exercise programme (or conventional care)	No
Secondary	Angina status		12wks after starting 12 week exercise programme (or conventional care)	No
Secondary	Angina Status		24wks after starting 12 week exercise programme (or conventional care)	No
Secondary	Anxiety Score		baseline	No
Secondary	Anxiety Score		6wks after starting 12 week exercise programme (or conventional care)	No
Secondary	Anxiety Score		12wks after starting 12 week exercise programme (or conventional care)	No
Secondary	Anxiety Score		24wks after starting 12 week exercise programme (or conventional care)	No
Secondary	Depression Score		6wks after starting 12 week exercise programme (or conventional care)	No
Secondary	Depression Score		baseline	No
Secondary	Depression Score		12wks after starting 12 week exercise programme (or conventional care)	No
Secondary	Depression Score		24wks after starting 12 week exercise programme (or conventional care)	No