Modulation of ischaemic induced cardiac dysfunction by remote pre-conditioning
| ISRCTN | ISRCTN42864201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42864201 |
| Secondary identifying numbers | N0544112277 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 22/08/2016
- 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 David Dutka
Scientific
Scientific
Box No 110
ACCI Level 6
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 331504 |
|---|---|
| dpd24@cam.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Modulation of ischaemic induced cardiac dysfunction by remote pre-conditioning |
| Study objectives | The effect of remote preconditioning on post-ischaemic left ventricular dysfunction (stunning) after dobutamine will be assessed by echocardiography in patients with single vessel coronary disease awaiting coronary angioplasty. |
| Ethics approval(s) | Cambridge LREC, September 2001 |
| Health condition(s) or problem(s) studied | Cardiovascular: Single vessel coronary disease |
| Intervention | Myocardial ischaemia is common in patients with coronary artery disease (CAD) and may be asymptomatic and occur during everyday life. Brief episodes of demand ischaemia, where the increase in coronary blood supply is insufficient to meet the increase in cardiac work, may result in both an adaptive change in metabolism and a transient reduction in regional left ventricular contractile function (stunning). The changes in contractile function can be assessed by echocardiography and from the basis of dobutamine stress echocardiography that is a well-validated non-invasive technique for the diagnosis and assessment of patients with CAD. Episodes of ischaemia in a remote organ (such as a limb) may modify the myocardial response to ischaemia and this study will use this technique to assess the myocardial response to dobutamine in patients with single vessel CAD. Using a randomised cross-over design, a baseline dobutamine stress study will be performed to confirm that stunning can be induced, with two further studies with and without remote preconditioning. The latter will be induced by inflating a blood pressure cuff in the non-dominant arm to 30 mmHg above systolic blood pressure for 5 min, deflated for 5 min and then repeated three times. At the end of these three cycles (that have previously been performed uneventfully in volunteers) the dobutamine stress echocardiogram will be performed using a standard clinical protocol with myocardial imaging every 3 min during the incremental increases in dobutamine dosage. Imaging will be repeated every 3 min for 3 h after the end of the dobutamine infusion. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dobutamine |
| Primary outcome measure | Added July 2008: Change in ejection fraction after remote preconditioning, compared to baseline. |
| Secondary outcome measures | Added July 2008: 1. Segmental LV wall tissue velocities 2. Rate pressure product 3. ECG ST deviation and chest pain score after remote preconditioning, compared to baseline |
| Overall study start date | 02/04/2002 |
| Completion date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 patients |
| Key inclusion criteria | Added July 2008: 1. Able to consent 2. Age >18 3. Coronary artery disease 4. Normal left ventricular function |
| Key exclusion criteria | Added July 2008: 1. Diabetes mellitus 2. Valvular heart disease 3. Permanent pacemaker 4. Left bundle branch block (LBBB) on electrocardiogram (ECG) 5. Myocardial infarction in the preceding 3 months 6. Not in sinus rhythm or taking nicorandil or glibenclamide medication |
| Date of first enrolment | 02/04/2002 |
| Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Cambridge Consortium - Addenbrooke's (UK)
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 | 01/04/2010 | Yes | No | |
| Results article | results | 01/09/2016 | Yes | No |
Editorial Notes
22/08/2016: Publication reference added.
