Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans

Phase 3

Completed

• Conditions: Ischemic Heart Disease
• Interventions: Other: Remote Ischemic Conditioning

• Registration Number: NCT02230098
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-10
• Study Start: 2013-08
• Status Verified: 2013-11
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Conditioning	Remote Ischemic Conditioning	By use of short-term obstruction of the blood supply to the arm

Primary Outcome Measures

Name	Time	Method
Changes in myocardial blood flow (MBF)	2 hours - Measurements will be done immediately before/after intervention	MBF before and after intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Region Central Denmark, Denmark