The Effect of Exercise on Peripheral Blood Gene Expression in Angina

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01147952
First received: June 18, 2010
Last updated: November 3, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Angina Pectoris
Behavioral: Structured exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Peripheral blood gene expression [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Peripheral blood gene expression [ Time Frame: 6wks after starting 12week exercise training (or conventional care) ] [ Designated as safety issue: No ]
  • peripheral blood gene expression [ Time Frame: 12 weeks after exercise training (or conventional care) ] [ Designated as safety issue: No ]
  • Peripheral blood gene expression [ Time Frame: 24 weeks after starting 12 weeks exercise training programme ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Angina status [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Angina status [ Time Frame: 6wks after starting 12 week exercise programme (or conventional care) ] [ Designated as safety issue: No ]
  • Angina status [ Time Frame: 12wks after starting 12 week exercise programme (or conventional care) ] [ Designated as safety issue: No ]
  • Angina Status [ Time Frame: 24wks after starting 12 week exercise programme (or conventional care) ] [ Designated as safety issue: No ]
  • Anxiety Score [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Anxiety Score [ Time Frame: 6wks after starting 12 week exercise programme (or conventional care) ] [ Designated as safety issue: No ]
  • Anxiety Score [ Time Frame: 12wks after starting 12 week exercise programme (or conventional care) ] [ Designated as safety issue: No ]
  • Anxiety Score [ Time Frame: 24wks after starting 12 week exercise programme (or conventional care) ] [ Designated as safety issue: No ]
  • Depression Score [ Time Frame: 6wks after starting 12 week exercise programme (or conventional care) ] [ Designated as safety issue: No ]
  • Depression Score [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Depression Score [ Time Frame: 12wks after starting 12 week exercise programme (or conventional care) ] [ Designated as safety issue: No ]
  • Depression Score [ Time Frame: 24wks after starting 12 week exercise programme (or conventional care) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 week exercise training 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.
No Intervention: Conventional Care

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147952

Contacts
Contact: Tim Chico, MD 00 44 114 222 2395/6 t.j.chico@sheffield.ac.uk

Locations
United Kingdom
NIHR Cardiovascular Biomedical Research Unit Not yet recruiting
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
  More Information

No publications provided by Sheffield Teaching Hospitals NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Timothy Chico, Senior Clinical Lecturer, University of Sheffield/NIHR Cardiovascular Biomedical Research Unit
ClinicalTrials.gov Identifier: NCT01147952     History of Changes
Other Study ID Numbers: STH15565
Study First Received: June 18, 2010
Last Updated: November 3, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
angina
gene expression
depression
anxiety

Additional relevant MeSH terms:
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014