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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01390129
First received: July 6, 2011
Last updated: October 23, 2012
Last verified: October 2012
  Purpose
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.

Condition Intervention
Aortic Valve Stenosis
Procedure: Control
Procedure: Remote ischemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Infarct size [ Time Frame: 72 hours ]
    Infarct size as assessed by 72 hours area under curve serum troponin-I


Enrollment: 100
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control Procedure: Control
Deflated blood pressure cuff placed on upper arm for 30min
Active Comparator: Remote ischemic preconditioning Procedure: Remote ischemic preconditioning
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390129

Locations
France
University Hospital, Angers
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Fabrice Prunier, MD, PhD University Hospital, Angers
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01390129     History of Changes
Other Study ID Numbers: AOI 2010-07
Study First Received: July 6, 2011
Last Updated: October 23, 2012

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on March 24, 2017