Back to resultsEffects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans (CONDI-PET)
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Remote Ischemic Conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring remote ischemic conditioning, ischemic heart disease
Eligibility Criteria
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
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Remote Ischemic Conditioning
Before Remote Ischemic Conditioning
Arm Description
By use of short-term obstruction of the blood supply to the arm
Outcomes
Primary Outcome Measures
Changes in myocardial blood flow (MBF)
MBF before and after intervention
Secondary Outcome Measures
Difference in MBF between ischemic and non-ischemic myocardial territories.
Difference in MBF between patients with and without ischemic heart disease detectable by Rb82-PET.
Cardioprotection by the intervention measured by an increase in myocardial salvage in isolated rabbit hearts studied in a Langendorff model.
Relation between changes in MBF and myocardial salvage in rabbit hearts
• Differences in MBF between regions supplied by coronary arteries subsequently undergoing percutaneous intervention (PCI) and regions supplied by arteries not undergoing PCI
Full Information
NCT ID
NCT02230098
First Posted
June 10, 2013
Last Updated
January 15, 2015
Sponsor
University of Aarhus
Collaborators
Leducq Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02230098
Brief Title
Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans
Acronym
CONDI-PET
Official Title
Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Leducq Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
remote ischemic conditioning, ischemic heart disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote Ischemic Conditioning
Arm Type
Experimental
Arm Description
By use of short-term obstruction of the blood supply to the arm
Arm Title
Before Remote Ischemic Conditioning
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Remote Ischemic Conditioning
Primary Outcome Measure Information:
Title
Changes in myocardial blood flow (MBF)
Description
MBF before and after intervention
Time Frame
2 hours - Measurements will be done immediately before/after intervention
Secondary Outcome Measure Information:
Title
Difference in MBF between ischemic and non-ischemic myocardial territories.
Time Frame
2 hours - Measurements will be done immediately before/after intervention
Title
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
Title
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
Title
Relation between changes in MBF and myocardial salvage in rabbit hearts
Time Frame
6 months following last patient last visit
Title
• 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roni Ranghøj Nielsen, MD, PhD
Organizational Affiliation
Department of Cardiology, Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans Erik Bøtker, Prof, MD, PhD, DMSc
Organizational Affiliation
Dept. of Cardiology, Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Region Central Denmark
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
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Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans
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