Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D Patterson

ORCID ID

Contact details

Clinic 3A
Diagnostic Block
Whittington Hospital
Highgate Hill
London
N19 5NF
United Kingdom
+44 (0)20 7272 5292
david.patterson@whittington.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0277138953

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

05/12/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2004

Recruitment end date

05/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinic 3A
London
N19 5NF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Whittington Hospital NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19124615

Publication citations

  1. Results

    Taggart P, Batchvarov VN, Sutton P, Young G, Young S, Patterson D, Repolarization changes induced by mental stress in normal subjects and patients with coronary artery disease: effect of nitroglycerine., Psychosom Med, 2009, 71, 1, 23-29, doi: 10.1097/PSY.0b013e31818a1d56.

Additional files

Editorial Notes