Angina PectorisNCT01147952
The Effect of Exercise on Peripheral Blood Gene Expression in Angina
A study testing Structured exercise training in people with Angina Pectoris, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Structured exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Cardiovascular Biomedical Research Unit
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina
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.
- Conditions
- Angina Pectoris
- Being tested
- Structured exercise training
- Keywords
- angina, gene expression, depression, anxiety
- Medical subject headings
- Angina Pectoris, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 12 week exercise training | Experimental | Not described Receives: Behavioral: Structured exercise training |
| Conventional Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood gene expression
Measured: baseline
Peripheral blood gene expression
Measured: 6wks after starting 12week exercise training (or conventional care)
peripheral blood gene expression
Measured: 12 weeks after exercise training (or conventional care)
Peripheral blood gene expression
Measured: 24 weeks after starting 12 weeks exercise training programme
Secondary outcomes (12)
Angina status
Measured: baseline
Angina status
Measured: 6wks after starting 12 week exercise programme (or conventional care)
Angina status
Measured: 12wks after starting 12 week exercise programme (or conventional care)
Angina Status
Measured: 24wks after starting 12 week exercise programme (or conventional care)
Anxiety Score
Measured: baseline
Anxiety Score
Measured: 6wks after starting 12 week exercise programme (or conventional care)
Anxiety Score
Measured: 12wks after starting 12 week exercise programme (or conventional care)
Anxiety Score
Measured: 24wks after starting 12 week exercise programme (or conventional care)
Depression Score
Measured: 6wks after starting 12 week exercise programme (or conventional care)
Depression Score
Measured: baseline
Depression Score
Measured: 12wks after starting 12 week exercise programme (or conventional care)
Depression Score
Measured: 24wks after starting 12 week exercise programme (or conventional care)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147952
- Sponsor's protocol ID
- STH15565
- Status last verified
- Apr 2016
- First submitted
- 18 Jun 2010
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bourke L, Tew GA, Milo M, Crossman DC, Saxton JM, Chico TJ. Study protocol: a randomised controlled trial investigating the effect of exercise training on peripheral blood gene expression in patients with stable angina. BMC Public Health. 2010 Oct 18;10:620. doi: 10.1186/1471-2458-10-620.
PubMed 20955605
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina
- ClinicalTrials.gov ID
- NCT01147952
- Acronym / sponsor ID
- STH15565
- Conditions
- Angina Pectoris
- Keywords
- angina, gene expression, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 week exercise training | Experimental | Behavioral: Structured exercise training |
| Conventional Care | No intervention | – |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured exercise trainingrandomised 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. | Behavioural | 12 week exercise training |
Primary outcome
Peripheral blood gene expression
Time frame: baseline
Peripheral blood gene expression
Time frame: 6wks after starting 12week exercise training (or conventional care)
peripheral blood gene expression
Time frame: 12 weeks after exercise training (or conventional care)
Peripheral blood gene expression
Time frame: 24 weeks after starting 12 weeks exercise training programme
12 secondary outcomes
Angina status
Time frame: baseline
Angina status
Time frame: 6wks after starting 12 week exercise programme (or conventional care)
Angina status
Time frame: 12wks after starting 12 week exercise programme (or conventional care)
Angina Status
Time frame: 24wks after starting 12 week exercise programme (or conventional care)
Anxiety Score
Time frame: baseline
Anxiety Score
Time frame: 6wks after starting 12 week exercise programme (or conventional care)
Anxiety Score
Time frame: 12wks after starting 12 week exercise programme (or conventional care)
Anxiety Score
Time frame: 24wks after starting 12 week exercise programme (or conventional care)
Depression Score
Time frame: 6wks after starting 12 week exercise programme (or conventional care)
Depression Score
Time frame: baseline
Depression Score
Time frame: 12wks after starting 12 week exercise programme (or conventional care)
Depression Score
Time frame: 24wks after starting 12 week exercise programme (or conventional care)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Derived from this study: PubMed 20955605Bourke L, Tew GA, Milo M, Crossman DC, Saxton JM, Chico TJ. Study protocol: a randomised controlled trial investigating the effect of exercise training on peripheral blood gene expression in patients with stable angina. BMC Public Health. 2010 Oct 18;10:620. doi: 10.1186/1471-2458-10-620.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured exercise training in people with Angina Pectoris, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral blood gene expression (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01147952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.