Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans

NCT ID: NCT02230098

Last Updated: 2015-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-10-31

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.

Detailed Description

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Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Remote Ischemic Conditioning

By use of short-term obstruction of the blood supply to the arm

Group Type EXPERIMENTAL

Remote Ischemic Conditioning

Intervention Type OTHER

Before Remote Ischemic Conditioning

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote Ischemic Conditioning

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leducq Foundation

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roni Ranghøj Nielsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Aarhus University Hospital

Hans Erik Bøtker, Prof, MD, PhD, DMSc

Role: STUDY_DIRECTOR

Dept. of Cardiology, Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, Region Central Denmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-10-72-124-13

Identifier Type: -

Identifier Source: org_study_id

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