Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/08/2016
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 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 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

Cambridge LREC, September 2001

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Dobutamine

Primary outcome measures

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 trial start date

02/04/2002

Overall trial end date

01/04/2005

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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

http://www.doh.gov.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20398869
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27539611

Publication citations

  1. Results

    Hoole SP, Heck PM, White PA, Read PA, Khan SN, West NE, O'Sullivan M, Dutka DP, Stunning and cumulative left ventricular dysfunction occurs late after coronary balloon occlusion in humans insights from simultaneous coronary and left ventricular hemodynamic assessment., JACC Cardiovasc Interv, 2010, 3, 4, 412-418, doi: 10.1016/j.jcin.2009.12.014.

  2. Results

    Ladwiniec A, White PA, Nijjer SS, O'Sullivan M, West NE, Davies JE, Hoole SP, Diastolic Backward-Traveling Decompression (Suction) Wave Correlates With Simultaneously Acquired Indices of Diastolic Function and Is Reduced in Left Ventricular Stunning, Circ Cardiovasc Interv, 2016, 9, 9, pii: e003779, doi: 10.1161/CIRCINTERVENTIONS.116.003779.

Additional files

Editorial Notes

22/08/2016: Publication reference added.