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Completed

NCT Number: NCT02342522

Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)

The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure at 12 months in patients presenting with a ST-elevation myocardial infarction and treated by percutaneous coronary intervention.

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Key information

Conditions

STEMI Cardiomyopathies Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Myocardial Reperfusion Injury Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

The CONDI2/ERIC-PPCI trial is a randomised controlled clinical trial investigating whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in 5400 patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Onset of STEMI symptoms within 12 hours, lasting for more than 30 minutes
  • Patients older than 18 years
  • Suspected STEMI (ST-elevation at the J-point in two contiguous leads with the cutoff points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads)

Exclusion criteria

  • Previous coronary artery bypass graft surgery
  • Myocardial infarction within the previous 30 days
  • Treatment with thrombolysis within the previous 30 days
  • Left bundle branch block
  • Patients treated with therapeutic hypothermia
  • Conditions precluding use of RIC (paresis of upper limb, use of an a-v shunt)
  • Life expectancy of less than 1 year due to non-cardiac pathology

Treatment and study plan

remote ischemic conditioning

Device

An automated autoRIC™ cuff will be placed on the upper arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle which will be undertaken 4 times in total.

Control

Device

An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.

Primary outcomes

  1. Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.

    Time frame: One year

Secondary outcomes

  1. Rates of cardiac death and HHF at 30 days.

    Time frame: 30 days

  2. Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.

    Time frame: 12 months

  3. TIMI flow post-PPCI.

    Time frame: 1 week

  4. Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).

    Time frame: One year

  5. Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers

    Time frame: 1 week

  6. CMR substudy: Cardiac MRI in first week and at 6 months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Barts & The London NHS Trust
  • Blackpool Victoria Hospital
  • Brighton and Sussex University Hospitals NHS Trust
  • British Heart Foundation
  • Central Denmark Region
  • Clinical Centre of Serbia
  • East Kent Hospitals University NHS Foundation Trust
  • East and North Hertfordshire NHS Trust
  • Guy's and St Thomas' NHS Foundation Trust
  • Heart of England NHS Trust
  • Hospital Universitario Central de Asturias
  • Imperial College Healthcare NHS Trust
  • Kettering General Hospital NHS Foundation Trust
  • King's College London
  • London School of Hygiene and Tropical Medicine
  • Manchester University NHS Foundation Trust
  • Mid and South Essex NHS Foundation Trust
  • Military Medical Academy, Belgrade, Serbia
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • North Cumbria University Hospitals NHS Trust
  • Odense University Hospital
  • Oxford University Hospitals NHS Trust
  • Papworth Hospital NHS Foundation Trust
  • Portsmouth Hospitals NHS Trust
  • Prehospital Emergency Medical Service, The North Denmark Region
  • Region Zealand
  • Region of Southern Denmark
  • Rigshospitalet, Denmark
  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
  • Royal Free Hospital NHS Foundation Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • The Danish Medical Research Council
  • The Leeds Teaching Hospitals NHS Trust
  • The Royal Wolverhampton Hospitals NHS Trust
  • United Lincolnshire Hospitals NHS Trust
  • University Hospitals Bristol and Weston NHS Foundation Trust
  • University Hospitals Coventry and Warwickshire NHS Trust
  • University Hospitals of North Midlands NHS Trust
  • University of Aarhus

Registry information

Official study title

Effect of Remote Ischaemic Conditioning on Clinical Outcomes in ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention (CONDI2/ERIC-PPCI)

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jan 21, 2015
Registry last updated
Aug 29, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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