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Completed

NCT Number: NCT01390129

Remote Ischemic Preconditioning in Aortic Valve Surgery

RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery. Infarct size will be determined by 72 hours area under curve of troponin-I.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Angers

Angers, 49933, France

About this study

The hypothesis tested in this research proposal is that remote ischemic preconditioning initiated immediately before aortic valve surgery reduces myocardial damage related to surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18
  • Aortic valve surgery for aortic stenosis
  • Written informed consent

Exclusion criteria

  • Aortic valve surgery combined with CABG or an other valve surgery
  • Previous Q-wave myocardial infarction or previous coronary artery bypass graft
  • Coronary artery stenosis >70%
  • Ejection fraction <35%
  • Surgery performed in emergency
  • Nicorandil ou metformin treatment within 8 days before surgery
  • 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

Remote ischemic preconditioning

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 before aortic clamping and repeated 3 times in total

Primary outcomes

  1. Infarct size

    Time frame: 72 hours

    Infarct size as assessed by 72 hours area under curve serum troponin-I

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)

Acronym: RIP-Valve

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 8, 2011
Registry last updated
Oct 24, 2012

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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