Modulation of ischaemic induced cardiac dysfunction by remote pre-conditioning

ISRCTN ISRCTN42864201
DOI https://doi.org/10.1186/ISRCTN42864201
Protocol serial number N0544112277
Sponsor Department of Health (UK)
Funder Cambridge Consortium - Addenbrooke's (UK)
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

Box No 110
ACCI Level 6
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom

+44 (0)1223 331504
dpd24@cam.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleModulation of ischaemic induced cardiac dysfunction by remote pre-conditioning
Study objectivesThe 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) studiedCardiovascular: Single vessel coronary disease
InterventionMyocardial 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Dobutamine
Primary outcome measure(s)

Added July 2008:
Change in ejection fraction after remote preconditioning, compared to baseline.

Key secondary outcome measure(s)

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

Completion date01/04/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration20
Key inclusion criteriaAdded July 2008:
1. Able to consent
2. Age >18
3. Coronary artery disease
4. Normal left ventricular function
Key exclusion criteriaAdded 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 enrolment02/04/2002
Date of final enrolment01/04/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

22/08/2016: Publication reference added.

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