Ischemic Heart DiseasePhase 3CONDI-PETNCT02230098
Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans
A Phase 3 study testing Remote Ischemic Conditioning in people with Ischemic Heart Disease, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Remote Ischemic Conditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ischemic Heart Disease
- Being tested
- Remote Ischemic Conditioning
- Keywords
- remote ischemic conditioning, ischemic heart disease
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic ConditioningOther
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning | Experimental | By use of short-term obstruction of the blood supply to the arm Receives: Other: Remote Ischemic Conditioning |
| Before Remote Ischemic Conditioning | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in myocardial blood flow (MBF)
MBF before and after intervention
Measured: 2 hours - Measurements will be done immediately before/after intervention
Secondary outcomes (5)
Difference in MBF between ischemic and non-ischemic myocardial territories.
Measured: 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.
Measured: 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.
Measured: 6 months following last patient last visit
Relation between changes in MBF and myocardial salvage in rabbit hearts
Measured: 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
Measured: 6 months following last patient last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Leducq Foundation
- Responsible party
- Sponsor
- Investigators
- Roni Ranghøj Nielsen, MD, PhD, Principal investigator, Department of Cardiology, Aarhus University HospitalHans Erik Bøtker, Prof, MD, PhD, DMSc, Study director, Dept. of Cardiology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230098
- Sponsor's protocol ID
- 1-10-72-124-13
- Acronym
- CONDI-PET
- Status last verified
- Nov 2013
- First submitted
- 10 Jun 2013
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans
- ClinicalTrials.gov ID
- NCT02230098
- Acronym / sponsor ID
- CONDI-PET / 1-10-72-124-13
- Conditions
- Ischemic Heart Disease
- Keywords
- remote ischemic conditioning, ischemic heart disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Leducq Foundation
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning | Experimental | Other: Remote Ischemic ConditioningBy use of short-term obstruction of the blood supply to the arm |
| Before Remote Ischemic Conditioning | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic Conditioning | Other | Remote Ischemic Conditioning |
Primary outcome
Changes in myocardial blood flow (MBF)
Time frame: 2 hours - Measurements will be done immediately before/after intervention
MBF before and after intervention
5 secondary outcomes
Difference in MBF between ischemic and non-ischemic myocardial territories.
Time frame: 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.
Time frame: 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.
Time frame: 6 months following last patient last visit
Relation between changes in MBF and myocardial salvage in rabbit hearts
Time frame: 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
Time frame: 6 months following last patient last visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roni Ranghøj Nielsen, MD, PhD principal investigator
Department of Cardiology, Aarhus University Hospital
Hans Erik Bøtker, Prof, MD, PhD, DMSc study director
Dept. of Cardiology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remote Ischemic Conditioning in people with Ischemic Heart Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in myocardial blood flow (MBF) (time frame: 2 hours - Measurements will be done immediately before/after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.