Clinical trial NCT02230098: Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans
Official title: Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Heart Disease
Keywords: remote ischemic conditioning
ischemic heart disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Leducq Foundation
First posted: 2014-09-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in myocardial blood flow (MBF)
timeFrame: 2 hours - Measurements will be done immediately before/after intervention
Secondary outcomes:
measure: Difference in MBF between ischemic and non-ischemic myocardial territories.
timeFrame: 2 hours - Measurements will be done immediately before/after intervention
measure: Difference in MBF between patients with and without ischemic heart disease detectable by Rb82-PET.
timeFrame: 2 hours - Measurements will be done immediately before/after intervention
measure: Cardioprotection by the intervention measured by an increase in myocardial salvage in isolated rabbit hearts studied in a Langendorff model.
timeFrame: 6 months following last patient last visit
measure: Relation between changes in MBF and myocardial salvage in rabbit hearts
timeFrame: 6 months following last patient last visit
measure: • Differences in MBF between regions supplied by coronary arteries subsequently undergoing percutaneous intervention (PCI) and regions supplied by arteries not undergoing PCI
timeFrame: 6 months following last patient last visit
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Region Central Denmark
Study officials:
affiliation: Department of Cardiology, Aarhus University Hospital
name: Roni Ranghøj Nielsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Cardiology, Aarhus University Hospital
name: Hans Erik Bøtker, Prof, MD, PhD, DMSc
role: STUDY_DIRECTOR
References: