Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Other: Remote Ischemic Conditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in MBF between ischemic and non-ischemic myocardial territories. |  | 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. |  | 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. |  | 6 months following last patient last visit | 
| Relation between changes in MBF and myocardial salvage in rabbit hearts |  | 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 |  | 6 months following last patient last visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischemic conditioning, ischemic heart disease