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Completed

NCT Number: NCT01247545

Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Essex Cardiothoracic Centre, Basildon, Essex, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischaemic preconditioning

Procedure

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

Procedure

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.

Primary outcomes

  1. Major adverse cardiac and cerebral events

    Time frame: One year post-surgery

    Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.

Secondary outcomes

  1. Peri-operative myocardial injury

    Time frame: 72 hours peri-operative period

    72 hours area under curve serum troponin-T

  2. LV ejection fraction

    Time frame: At one year

    Echo determined LV ejection fraction

  3. Acute kidney injury

    Time frame: Peri-operative

    Acute kidney injury score and 24 hour area under curve serum NGAL

  4. 30 day MACCE

    Time frame: 30 days post surgery

    Major adverse cardiac and cerebral events 30 days post surgery

  5. All cause death

    Time frame: 1 year post surgery

  6. Length of ITU stay

    Time frame: ITU stay

  7. Length of hospital stay

    Time frame: Until hospital discharge

  8. Inotrope score

    Time frame: 72 hours post surgery

    Inotrope score after 72 hours

  9. 6 minute Walk Test

    Time frame: 6 weeks and 12 months post surgery

  10. Quality of Life

    Time frame: 6 weeks, 3/6/9 and 12 months post surgery

    Quality of Life assessed using the EQ-5D measurement

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in Coronary Artery Bypass Graft Surgery

Acronym: ERICCA

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2010
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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