Myocardial Physiology And Microanatomy In Individuals Undergoing Heart Surgery (TRIMRIPC)

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01308138
First received: February 2, 2011
Last updated: August 1, 2013
Last verified: July 2013

February 2, 2011
August 1, 2013
January 2011
May 2013   (final data collection date for primary outcome measure)
Mitochondrial respiration [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Oxygraph (Strathkelvin)
Mitochondrial respiration adaptations on myocardium in patients undergoing coronary bypass surgery or heart transplantation. [ Time Frame: February 2011 to november 2012: Data collection ] [ Designated as safety issue: No ]
We want control if mitochondrial respiration is reduced in patients with heart failure compared to non-heart failure, and if the ischemic period during surgery reduces respiration. Another aspect is to reveal if exercise training and remote ischemic preconditioning give protection to the heart during surgery. For patients with a transplanted heart it is a goal to investigate whether exercise training improves myocardial mitochondrial respiration.
Complete list of historical versions of study NCT01308138 on ClinicalTrials.gov Archive Site
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Myocardial Physiology And Microanatomy In Individuals Undergoing Heart Surgery
Study of Gaining Further Understanding of the Underlying Mechanisms of Myocardial Function

The main focus of the project is to determine to what degree myocardial energy metabolism is linked to impaired function in human cardiomyocytes, whether exercise training and remote ischemic preconditioning can restore cardiomyocyte function and whether this is linked to improved mitochondrial and cell function.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Myocardial Injury
  • Behavioral: Exercise training
    exercise training
  • Procedure: remote ischemic preconditioning
    remote ischemic preconditioning
  • Experimental: ExerciseTr
    Intervention: Behavioral: Exercise training
  • Experimental: Remote ischemic preconditioning group
    Intervention: Procedure: remote ischemic preconditioning
  • No Intervention: Control patient group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing coronary heart surgery and heart transplantation

Exclusion Criteria:

  • myocardial infarction closer than 4 weeks to project start, serious valve defects, diabetes, unstable angina, uncontrolled hypertension, kidney failure (creatinin > 140)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01308138
TRIMRIPC
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Katrine Hordnes, MD NTNU
Norwegian University of Science and Technology
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP