Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans

Ischemic Heart Disease Clinical Trial

— CONDI-PET  

Official title:

Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230098
• Other study ID #: 1-10-72-124-13
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2013
• Last updated: January 15, 2015
• Start date: August 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• Remote Ischemic Conditioning

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Region Central Denmark

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Leducq Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in myocardial blood flow (MBF)	MBF before and after intervention	2 hours - Measurements will be done immediately before/after intervention	No
Secondary	Difference in MBF between ischemic and non-ischemic myocardial territories.		2 hours - Measurements will be done immediately before/after intervention	No
Secondary	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	No
Secondary	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	No
Secondary	Relation between changes in MBF and myocardial salvage in rabbit hearts		6 months following last patient last visit	No
Secondary	• 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	No