Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG Surgery (ERICCA)
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| ClinicalTrials.gov Identifier: NCT01247545 |
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Recruitment Status :
Completed
First Posted : November 24, 2010
Last Update Posted : May 29, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Heart Disease | Procedure: Remote ischaemic preconditioning Procedure: Control | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1612 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in Coronary Artery Bypass Graft Surgery |
| Study Start Date : | November 2010 |
| Actual Primary Completion Date : | March 2015 |
| Actual Study Completion Date : | March 2015 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Control
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.
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Procedure: Control
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. |
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Active Comparator: Remote ischaemic conditioning
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.
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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. |
- Major adverse cardiac and cerebral events [ Time Frame: One year post-surgery ]Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.
- Peri-operative myocardial injury [ Time Frame: 72 hours peri-operative period ]72 hours area under curve serum troponin-T
- LV ejection fraction [ Time Frame: At one year ]Echo determined LV ejection fraction
- Acute kidney injury [ Time Frame: Peri-operative ]Acute kidney injury score and 24 hour area under curve serum NGAL
- 30 day MACCE [ Time Frame: 30 days post surgery ]Major adverse cardiac and cerebral events 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 [ Time Frame: 72 hours post surgery ]Inotrope score after 72 hours
- 6 minute Walk Test [ Time Frame: 6 weeks and 12 months post surgery ]
- Quality of Life [ Time Frame: 6 weeks, 3/6/9 and 12 months post surgery ]Quality of Life assessed using the EQ-5D measurement
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing CABG with or without valve surgery using blood cardioplegia
- Patients aged 18 years and above
- Patients with an additive Euroscore greater than or equal to 5
Exclusion Criteria:
- Cardiogenic shock
- Cardiac arrest on current admission
- Pregnancy
- Significant peripheral arterial disease affecting the upper limbs
- Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio)
- Patients with significant pulmonary disease (FEV1<40% predicted)
- Patients with known renal failure with a GFR<30 mL/min/1.73 m2
- Patients on glibenclamide or nicorandil, as these medications may interfere with RIC
- Patients recruited into another study which may impact on the ERICCA study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247545
Show 28 study locations
| Principal Investigator: | Derek J Hausenloy, MD PhD | University College, London |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT01247545 |
| Other Study ID Numbers: |
10/0303 |
| First Posted: | November 24, 2010 Key Record Dates |
| Last Update Posted: | May 29, 2015 |
| Last Verified: | May 2015 |
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Remote ischemic preconditioning Coronary artery bypass graft surgery Cardioprotection Clinical Outcomes |
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Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |