The effect of mental stress on the heart in patients with coronary artery disease. Part 1. A study of mechanisms that Predispose to abnormal heart rhythms. Part 2. A study of Management Using Relaxation Techniques.
| ISRCTN | ISRCTN21422835 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21422835 |
| Secondary identifying numbers | N0277138953 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 13/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr D Patterson
Scientific
Scientific
Clinic 3A
Diagnostic Block
Whittington Hospital
Highgate Hill
London
N19 5NF
United Kingdom
| Phone | +44 (0)20 7272 5292 |
|---|---|
| david.patterson@whittington.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To test the hypothesis that in patients with abnormal coronary arteries, mental stress induces electrical instability in the heart not simply by a direct effect of increased sympathetic nerve activity on the heart, but by creating an oxygen supply/demand mismatch i.e. a low grade ischaemia, which is unrecognised both clinically and on the conventional electrocardiogram (ECG). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Coronary artery disease |
| Intervention | Patients attending Cardiology Outpatients clinic will follow one of the 4 protocols. 1. They will either receive Glycerol trinitrite (commonly used for angina) or placebo tablets under the tongue and be connected to an electrocardiogram (ECG) recorder and given 2 mental stress tasks e.g. mental arithmetic of subtracting numbers as rapidly as possible in 5 minutes and after 5 minutes rest make a 5 minute speech. The tests are repeated one week later but with the other tablet. 2. For patients taking Nicorandil, the same tests apply unless nicorandil is given before repeat test. Patient will need a third test without any tablets under tongue. 3. Patient will wear ECG recorder for 24 hours with 4 sticky probes attached to chest, whilst they go about everyday activities keeping a diary 4. In the Cardiology Outpatient Clinic the patient will be attached to the ECG and will have to recall 2 negative emotional experiences form the past and 2 positive experiences after a 5 minute rest. One group will be taught how to induce relaxation by self hypnosis. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2004 |
| Completion date | 05/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | 20 patients attending hospital for management of their coronary artery disease. 10 patients on medication with Nicorandil and 10 not receiving Nicorandil. Each group will attend the Cardiology Out Patient Dept by appointment on two occasions at weekly intervals for ECG. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 05/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinic 3A
London
N19 5NF
United Kingdom
N19 5NF
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Whittington Hospital NHS Trust
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No |
