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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19124615
Publication citations
-
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.