Contact information
Type
Scientific
Contact name
Dr David Dutka
ORCID ID
Contact details
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
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0544112277
Study information
Scientific title
Modulation of ischaemic induced cardiac dysfunction by remote pre-conditioning
Acronym
Study hypothesis
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
01/04/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Added July 2008:
1. Able to consent
2. Age >18
3. Coronary artery disease
4. Normal left ventricular function
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
20 patients
Participant 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
Recruitment start date
02/04/2002
Recruitment end date
01/04/2005
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Cambridge Consortium - Addenbrooke's (UK)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |