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

Summary

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.

Conditions

• STEMI
• Myocardial Reperfusion Injury

Interventions

DEVICE

Remote ischemic conditioning

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.

DEVICE

Control

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

Sponsors & Collaborators

• British Heart Foundation

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• King's College London

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• University of Aarhus

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Hospital Universitario Central de Asturias

  collaborator OTHER

• Clinical Centre of Serbia

  collaborator OTHER

• Military Medical Academy, Belgrade, Serbia

  collaborator OTHER

• Central Denmark Region

  collaborator OTHER

• Region of Southern Denmark

  collaborator OTHER

• Prehospital Emergency Medical Service, The North Denmark Region

  collaborator UNKNOWN

• Region Zealand

  collaborator OTHER

• The Danish Medical Research Council

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• North Cumbria University Hospitals NHS Trust

  collaborator OTHER

• Barts & The London NHS Trust

  collaborator OTHER

• Mid and South Essex NHS Foundation Trust

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• Norfolk and Norwich University Hospitals NHS Foundation Trust

  collaborator OTHER

• The Royal Wolverhampton Hospitals NHS Trust

  collaborator OTHER_GOV

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• East and North Hertfordshire NHS Trust

  collaborator OTHER_GOV

• Portsmouth Hospitals NHS Trust

  collaborator OTHER_GOV

• United Lincolnshire Hospitals NHS Trust

  collaborator OTHER

• Papworth Hospital NHS Foundation Trust

  collaborator OTHER_GOV

• Blackpool Victoria Hospital

  collaborator OTHER

• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• Brighton and Sussex University Hospitals NHS Trust

  collaborator OTHER

• University Hospitals Coventry and Warwickshire NHS Trust

  collaborator OTHER

• University Hospitals of North Midlands NHS Trust

  collaborator OTHER

• Heart of England NHS Trust

  collaborator OTHER

• Kettering General Hospital NHS Foundation Trust

  collaborator OTHER

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• University Hospitals Bristol and Weston NHS Foundation Trust

  collaborator OTHER

• East Kent Hospitals University NHS Foundation Trust

  collaborator OTHER_GOV

• University College, London

  lead OTHER

Principal Investigators

• Derek Hausenloy, MD PhD · The Hatter Cardiovascular Institute, University College London

• Hans Erik Botker, MD PhD · University of Aarhus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2019-03-31

Completion

2019-03-31

Countries

• Denmark
• Serbia
• Spain
• United Kingdom

Study Locations