NCT02230098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 16, 2015

Status Verified

November 1, 2013

Enrollment Period

1.2 years

First QC Date

June 10, 2013

Last Update Submit

January 15, 2015

Conditions

Ischemic Heart Disease

Keywords

remote ischemic conditioningischemic heart disease

Outcome Measures

Primary Outcomes (1)

  • Changes in myocardial blood flow (MBF)

    MBF before and after intervention

    2 hours - Measurements will be done immediately before/after intervention

Secondary Outcomes (5)

  • 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

Study Arms (2)

Remote Ischemic Conditioning

EXPERIMENTAL

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

Other: Remote Ischemic Conditioning

Before Remote Ischemic Conditioning

NO INTERVENTION

Interventions

Remote Ischemic ConditioningOTHER
Remote Ischemic Conditioning

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Region Central Denmark, 8200, Denmark

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Roni Ranghøj Nielsen, MD, PhD

    Department of Cardiology, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Hans Erik Bøtker, Prof, MD, PhD, DMSc

    Dept. of Cardiology, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

September 3, 2014

Study Start

August 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 16, 2015

Record last verified: 2013-11

Locations

DK(1)