A Phase 3 interventional study of Remote ischaemic preconditioning and Control in Coronary Heart Disease, sponsored by University College, London. Completed at 28 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-29.
Sponsored by University College, London · Phase 3, Interventional, and Treatment
Coronary heart disease (CHD) is the leading cause of death in the UK, accounting for 124,000 deaths (2006) and costing the UK economy over £7.9 billion a year. Patients with severe CHD are usually treated by coronary artery bypass graft (CABG) surgery, the risks of which are increasing due to older and sicker patients being operated on. New treatment strategies are therefore required to improve health outcomes in these high-risk patients undergoing CABG with or without valve (CABG±valve) surgery.
The hypothesis tested in this research proposal is that remote ischaemic preconditioning (RIC), a virtually cost-free, non-pharmacological and simple non-invasive strategy for reducing the damage to the heart muscle at the time of surgery, improves health outcomes in high-risk patients undergoing CABG±valve surgery.
In this research project, 1610 high-risk patients undergoing CABG±valve surgery will be recruited via 28 UK hospitals performing heart surgery. Patients will be randomly allocated to receive either RIC or control. For RIC, a blood pressure cuff will be placed on the upper arm to temporarily deprive it of oxygen and nutrients, an intervention which has been shown in the investigators pilot studies to reduce damage to the heart muscle by up to 40% during CABG±valve surgery. The investigators will determine whether RIC can improve health outcomes in terms of better patient survival, less heart attacks and strokes, shorter hospital stay; less damage to the heart, kidney and brain during surgery; better heart function post-surgery and less chance of developing heart failure; better exercise tolerance and quality of life.
2,867 studies on the registry are indexed under Coronary Disease; 309 are open to participants now.
This study's enrollment of 1,612 is above the median of 124 across 1,601 interventional studies indexed under Coronary Disease.
Browse Coronary Disease studies →University College, London is the lead sponsor of 647 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
Control treatment (sham RIC) will consist of four 5-minute simulated inflations of a blood pressure cuff placed on the upper arm. The inflations will be separated by 5-minute periods when the blood pressure cuff will be deflated.
Procedure: Control
Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times.
Procedure: Remote ischaemic preconditioning
Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times.
Control treatment (sham RIC) will consist of four 5-minute simulated inflations of a blood pressure cuff placed on the upper arm. The inflations will be separated by 5-minute periods when the blood pressure cuff will be deflated.
Major adverse cardiac and cerebral events
Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.
Time frame: One year post-surgery
Peri-operative myocardial injury
72 hours area under curve serum troponin-T
Time frame: 72 hours peri-operative period
LV ejection fraction
Echo determined LV ejection fraction
Time frame: At one year
Acute kidney injury
Acute kidney injury score and 24 hour area under curve serum NGAL
Time frame: Peri-operative
30 day MACCE
Major adverse cardiac and cerebral events 30 days post surgery
Time frame: 30 days post surgery
All cause death
Time frame: 1 year post surgery
Length of ITU stay
Time frame: ITU stay
Length of hospital stay
Time frame: Until hospital discharge
Inotrope score
Inotrope score after 72 hours
Time frame: 72 hours post surgery
6 minute Walk Test
Time frame: 6 weeks and 12 months post surgery
Quality of Life
Quality of Life assessed using the EQ-5D measurement
Time frame: 6 weeks, 3/6/9 and 12 months post surgery
The record gives a start of Nov 2010, a primary completion of Mar 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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