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NCT Number: NCT01390142

Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction

RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Angers - Service de Cardiologie

Angers, 49933, France

About this study

In the management of STEMI, prompt reperfusion of the jeopardized myocardium is the most effective way to limit infarct size, which is a major determinant of morbidity and mortality. However, restoration of blood flow may paradoxically have deleterious consequences and lead to lethal myocardial ischemia-reperfusion injury. Local ischemic postconditioning (IPost) and remote ischemic preconditioning (RIPer) are promising methods to decrease ischemia-reperfusion injury.

The hypothesis tested in this research proposal is that RIPer initiated at the time of the admission in the cathlab reduces infarct size in STEMI patients treated with PCI. Furthermore, the investigators will determine whether a combined approach RIPer + IPost can further reduce infarct size.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18
  • ST-Segment elevation myocardial infarction <6h
  • Written informed consent

Exclusion criteria

  • Previous Q-wave myocardial infarction or previous coronary artery bypass graft
  • Cardiogenic shock
  • Cardiac arrest resuscitated before angioplasty
  • Infarct related artery : circumflex coronary artery, right coronary artery after segment 3, left main, diagonal and marginal branches, and all coronary artery with jeopardized myocardium estimated too small.
  • TIMI 2 or 3 before angioplasty
  • Collateral branches Rentrop >1
  • TIMI 0 or 1 flow grade after PCI
  • Any contraindications to magnetic resonance imaging
  • Allergy to gadolinium
  • Patient refusal / patient not having provided written informed consent

Treatment and study plan

Control

Procedure

Deflated blood pressure cuff placed on upper arm for 30min

RIPer

Procedure

Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total.

RIPer + IPost

Procedure

Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total. Within the first minute of re-established coronary flow by primo-stenting, the same balloon is re-inflated for 1 min and then deflated for 1min. This procedure of balloon inflation/deflation is repeated 4 times in total.

Primary outcomes

  1. Infarct size

    Time frame: 3 months

    Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up

Secondary outcomes

  1. Microvascular obstruction

    Time frame: 5 days

    Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up

  2. Left ventricular remodeling

    Time frame: 3 months

    Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Fédération Française de Cardiologie
  • Société Française de Cardiologie

Registry information

Official study title

Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)

Acronym: RIRE-1

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 8, 2011
Registry last updated
Oct 18, 2013

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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