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Completed

NCT Number: NCT02230098

Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans

Cardiovascular disease is the second leading cause of death in Denmark, and ischemic heart disease accounts for the bulk of it. The purpose of this study is to clarify whether a mechanical method of remote ischemic conditioning in the form of short-term obstruction of the blood supply to the arm, can improve the heart's blood supply in patients with ischemic heart disease. This will be attempted through experiments on patients with ischemic heart disease and experimental animal studies with simulated cardiovascular disease.

This study will help to clarify whether remote ischemic preconditioning can be used to treat patients with ischemic heart disease.

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aarhus University Hospital

Aarhus, Region Central Denmark, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients referred for routine myocardial Rb82-PET scanning at Dept. of Nuclear Medicine & PET center, Aarhus University Hospital, Skejby, Denmark.
  • Able to understand the written patient information and to give informed consent.

Exclusion criteria

  • Patients not undergoing Rb82-PET with adenosine stress test.
  • Strenuous exercise (running, bicycling, fitness), intake of beta-blockers or alcohol intake on the day before and on the day of investigation.
  • Pregnant/nursing women.
  • Fertile women not using contraceptives.
  • Patients in dialysis treatment.
  • Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation.
  • Known type 2 diabetes

Treatment and study plan

Remote Ischemic Conditioning

Other

Primary outcomes

  1. Changes in myocardial blood flow (MBF)

    Time frame: 2 hours - Measurements will be done immediately before/after intervention

    MBF before and after intervention

Secondary outcomes

  1. Difference in MBF between ischemic and non-ischemic myocardial territories.

    Time frame: 2 hours - Measurements will be done immediately before/after intervention

  2. Difference in MBF between patients with and without ischemic heart disease detectable by Rb82-PET.

    Time frame: 2 hours - Measurements will be done immediately before/after intervention

  3. Cardioprotection by the intervention measured by an increase in myocardial salvage in isolated rabbit hearts studied in a Langendorff model.

    Time frame: 6 months following last patient last visit

  4. Relation between changes in MBF and myocardial salvage in rabbit hearts

    Time frame: 6 months following last patient last visit

  5. • Differences in MBF between regions supplied by coronary arteries subsequently undergoing percutaneous intervention (PCI) and regions supplied by arteries not undergoing PCI

    Time frame: 6 months following last patient last visit

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Leducq Foundation

Registry information

Acronym: CONDI-PET

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 3, 2014
Registry last updated
Jan 16, 2015

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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