Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans (CONDI-PET)

January 15, 2015 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

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

  • Denmark
    • Region Central Denmark
      • Aarhus, Region Central Denmark, Denmark, 8200
        • Aarhus 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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote Ischemic Conditioning
By use of short-term obstruction of the blood supply to the arm
Other: Remote Ischemic Conditioning
No Intervention: Before Remote Ischemic Conditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in myocardial blood flow (MBF)
Time Frame: 2 hours - Measurements will be done immediately before/after intervention
MBF before and after intervention
2 hours - Measurements will be done immediately before/after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in MBF between ischemic and non-ischemic myocardial territories.
Time Frame: 2 hours - Measurements will be done immediately before/after intervention
2 hours - Measurements will be done immediately before/after intervention
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
2 hours - Measurements will be done immediately before/after intervention
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
6 months following last patient last visit
Relation between changes in MBF and myocardial salvage in rabbit hearts
Time Frame: 6 months following last patient last visit
6 months following last patient last visit
• 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
6 months following last patient last visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Leducq Foundation

Investigators

  • Principal Investigator: Roni Ranghøj Nielsen, MD, PhD, Department of Cardiology, Aarhus University Hospital
  • Study Director: Hans Erik Bøtker, Prof, MD, PhD, DMSc, Dept. of Cardiology, Aarhus University Hospital

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, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Estimate)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-124-13

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.

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