- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01740102
Clinical Value of Remote Ischemic Preconditioning
August 3, 2016 updated by: Norwegian University of Science and Technology
Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?
Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs.
Further improvement of cardioprotection is therefore necessary.
Remote ischemic preconditioning (RIPC) is an easy and non-invasive method.
Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown.
The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway
- St Olavs Hospital Trondheim University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elective isolated on-pump CABG surgery
- Informed consent
Exclusion Criteria:
- Patients with a severe pulmonary disease
- Patients with renal failure (GFR<30 mL/min/1.73 m2)
- Patients with liver failure
- Peripheral vascular disease affecting the upper limbs
- Patients on sulfonylurea derivatives.
- Patients with atrial fibrillation in their case history
- Prior cardiac surgery (Re-operations)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RIPC
Remote ischemic preconditioning (RIPC) in the operating theatre after induction of anaesthesia and before surgery.
|
The remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations.
The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes.
This cycle will be performed three times in total.
The entire preconditioning will therefore last for 25 minutes.
Other Names:
|
No Intervention: No RIPC
Patients in the control group will not receive remote ischemic preconditioning before the surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative atrial fibrillation
Time Frame: Up to 10 days after surgery
|
A patient will be classified as belonging to the postoperative atrial fibrillation group if they have any episode of atrial fibrillation, measured by telemetry, lasting more than 1 minute during their postoperative days at the hospital.
|
Up to 10 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay
Time Frame: Maximum 14 days
|
Maximum 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Alexander Wahba, MD prof, Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway, and Department of Cardiothoracic Surgery, St. Olavs Hospital, Trondheim, Norway.
- Principal Investigator: Lars Erik B Krogstad, Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
November 21, 2012
First Submitted That Met QC Criteria
December 3, 2012
First Posted (Estimate)
December 4, 2012
Study Record Updates
Last Update Posted (Estimate)
August 4, 2016
Last Update Submitted That Met QC Criteria
August 3, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/2525
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Diseases
-
Baker Heart and Diabetes InstitutePrincess Alexandra Hospital, Brisbane, Australia; Royal Perth Hospital; Alice... and other collaboratorsRecruitingHeart Failure | Valve Heart DiseaseAustralia
-
Medical University of ViennaUnknownHeart Diseases | Heart Failure | Valvular Heart DiseaseAustria
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Abiomed Inc.RecruitingHeart Diseases | Acute Decompensated Heart Failure | Congestive Heart Failure | Acute Heart FailureUnited States
-
Kathirvel SubramaniamUniversity of Maryland, Baltimore; CSL BehringRecruitingHeart Failure,Congestive | Heart Disease End StageUnited States
-
Wuerzburg University HospitalRecruitingHeart Failure | Chronic Heart Failure | Chronic Heart DiseaseGermany
-
University of MichiganTerminatedDiastolic Heart Failure | Hypertensive Heart DiseaseUnited States
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Heart Failure | Valvular Heart Disease | Biochemical DysfunctionGreece
-
University College, LondonBritish Heart Foundation; Horizon 2020 - European CommissionRecruitingValvular Heart DiseaseUnited Kingdom
Clinical Trials on RIPC
-
Helsinki University Central HospitalAcademy of Finland; Finska Läkaresällskapet (funding); Helsinki University Hospital...Recruiting
-
Oladipupo Olafiranye, MD, MSNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingContrast-induced Acute Kidney InjuryUnited States
-
Liverpool John Moores UniversityCompletedCardiovascular Disease RiskUnited Kingdom
-
Westfälische Wilhelms-Universität MünsterRecruitingSepsis | Acute Kidney Injury | Critically IllGermany
-
Seoul National University HospitalRecruitingIschemic Reperfusion Injury | Radiotherapy | Other Reconstructive SurgeryKorea, Republic of
-
Seoul National University HospitalCompletedRemote Ischemic PreconditioningKorea, Republic of
-
Fundación Centro Nacional de Investigaciones Cardiovasculares...European CommissionRecruitingLymphoma | Anthracycline-induced Cardiac ToxicityNetherlands, Spain, Denmark, Germany, France, Portugal
-
Shanghai Zhongshan HospitalCompletedCardiac SurgeryChina
-
Changi General HospitalUniversity College Hospital GalwayCompletedContrast Induced Nephropathy | Remote Ischaemic PreconditioningSingapore
-
Mid Western Regional Hospital, IrelandUnknownPeripheral Vascular DiseaseIreland