Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG Surgery (ERICCA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01247545
First received: November 22, 2010
Last updated: October 22, 2014
Last verified: October 2014

November 22, 2010
October 22, 2014
November 2010
March 2015   (final data collection date for primary outcome measure)
Major adverse cardiac and cerebral events [ Time Frame: One year post-surgery ] [ Designated as safety issue: Yes ]
Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.
Major adverse cardiac and cerebral events [ Time Frame: One year post-surgery ] [ Designated as safety issue: Yes ]
Combined endpoint of Cardiovascular death, Reinfarction, Revascularisation and Stroke.
Complete list of historical versions of study NCT01247545 on ClinicalTrials.gov Archive Site
  • Peri-operative myocardial injury [ Time Frame: 72 hours peri-operative period ] [ Designated as safety issue: Yes ]
    72 hours area under curve serum troponin-T
  • LV ejection fraction [ Time Frame: At one year ] [ Designated as safety issue: No ]
    Echo determined LV ejection fraction
  • Acute kidney injury [ Time Frame: Peri-operative ] [ Designated as safety issue: Yes ]
    Acute kidney injury score and 24 hour area under curve serum NGAL
  • 30 day MACCE [ Time Frame: 30 days post surgery ] [ Designated as safety issue: Yes ]
    Major adverse cardiac and cerebral events 30 days post surgery
  • All cause death [ Time Frame: 1 year post surgery ] [ Designated as safety issue: Yes ]
  • Length of ITU stay [ Time Frame: ITU stay ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
  • Inotrope score [ Time Frame: 72 hours post surgery ] [ Designated as safety issue: No ]
    Inotrope score after 72 hours
  • 6 minute Walk Test [ Time Frame: 6 weeks and 12 months post surgery ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 weeks, 3/6/9 and 12 months post surgery ] [ Designated as safety issue: No ]
    Quality of Life assessed using the EQ-5D measurement
  • Peri-operative myocardial injury [ Time Frame: 72 hours peri-operative period ] [ Designated as safety issue: Yes ]
    72 hours area under curve serum troponin-T
  • LV ejection fraction [ Time Frame: At one year ] [ Designated as safety issue: No ]
    Echo determined LV ejection fraction
  • Acute kidney injury [ Time Frame: Peri-operative ] [ Designated as safety issue: Yes ]
    Acute kidney injury score and 24 hour area under curve serum NGAL
Not Provided
Not Provided
 
Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG Surgery
Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in Coronary Artery Bypass Graft Surgery

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Heart Disease
  • 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.
  • 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.
  • 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.
    Intervention: Procedure: Control
  • 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.
    Intervention: Procedure: Remote ischaemic preconditioning

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1610
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients undergoing CABG with or without valve surgery using blood cardioplegia
  2. Patients aged 18 years and above
  3. Patients with an additive Euroscore greater than or equal to 5

Exclusion Criteria:

  1. Cardiogenic shock
  2. Cardiac arrest on current admission
  3. Pregnancy
  4. Significant peripheral arterial disease affecting the upper limbs
  5. Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio)
  6. Patients with significant pulmonary disease (FEV1<40% predicted)
  7. Patients with known renal failure with a GFR<30 mL/min/1.73 m2
  8. Patients on glibenclamide or nicorandil, as these medications may interfere with RIC
  9. Patients recruited into another study which may impact on the ERICCA study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01247545
10/0303
Yes
University College, London
University College, London
Not Provided
Principal Investigator: Derek J Hausenloy, MD PhD University College, London
University College, London
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP