Angina PectorisMICS-ReduceNCT06033495
Myocardial Ischemia After Coronary Sinus Reduction Stent Implantation
An observational study of Angina Pectoris, run by Oslo University Hospital.
Trial summary
Chronic angina pectoris refractory to medical and revascularization therapies is a disabling medical condition and a major public health problem. Patients with refractory angina have limited treatment options. One proposed therapy modality is transcatheter implantation of a reduction stent in the coronary sinus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Coronary sinus reduction stent
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Jun 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with coronary artery disease and refractory angina who are under clinical care are informed and screened for participation if consent is provided.
Who may be able to join
- Coronary artery disease and refractory angina
- Clinical indication for coronary sinus reduction stent implantation
- Written informed consent
- Anticipated compliance with protocol
Who cannot join
- Ineligibility for coronary sinus reduction stent implantation
- Lack of informed consent
- Not expected to comply with protocol
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Myocardial Ischemia by 15O-H2O PET/CT in Patients With Coronary Artery Disease and Refractory Angina - Evaluation of the Coronary Sinus Reduction Stent Method
Chronic angina pectoris refractory to medical and revascularization therapies is a disabling medical condition and a major public health problem. Patients with refractory angina have limited treatment options. One proposed therapy modality is transcatheter implantation of a reduction stent in the coronary sinus. Coronary sinus reduction stents have been shown to reduce angina burden considerably and to improve quality of life. The reduction stent is assumed to increase myocardial perfusion and reduce myocardial ischemia, but the mechanism of action is poorly understood.
The aim of this project is to assess the myocardial ischemia burden in patients with refractory angina who are undergoing a transcatheter coronary sinus reducer procedure. This is a clinical non-randomized self-controlled cohort study with blinded outcome adjudication for changes in myocardial perfusion. Patients with refractory angina will be systematically examined before implantation of the coronary sinus reduction stent and after 6 months. The primary outcome, changes in myocardial perfusion on the gold standard 15O-H2O PET/CT will be evaluated on blinded perfusion scans where the stent is invisible. To provide context to the findings, we will also evaluate whether changes in myocardial ischemia are associated with less angina and better cardiac function parameters. Effects of stent implantation on angina symptoms and quality of life could be affected by a placebo effect.
Treatment options for patients with refractory angina is needed, and results from the present study will explore if coronary sinus reduction stents are improving myocardial ischemia in this patient group. Signs of improved objective perfusion will inspire confidence in the method.
- Conditions
- Angina Pectoris
- Being tested
- Coronary sinus reduction stent
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary sinus reduction stentDevice
Percutaneous stent implantation to reduce the dimension of the coronary sinus
| Study group | Role | What they receive |
|---|---|---|
| Patients with refractory angina undergoing coronary sinus reduction stent implantation | Not described Receives: Device: Coronary sinus reduction stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial ischemia
Change in myocardial flow reserve on 15O-H2O PET/CT
Measured: 6 months
Secondary outcomes (4)
Change in angina burden
Seattle angina questionnaire (SAQ-7) score ranging 0 (bad) -100 (good) will be assessed at baseline and after 6 months.
Measured: 6 months
Change in quality of life
Kansas City Cardiomyopathy Questionnaire (KCCQ) score ranging 0 (bad) -100 (good) will be assessed at baseline and after 6 months.
Measured: 6 months
Change in exercise capacity
Maximum oxygen extraction on cardiopulmonary exercise test assessed at baseline and after 6 months.
Measured: 6 months
Change in coronary microcirculation
Invasive assessment of coronary flow reserve (CFR) at baseline and at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Øyvind Lie, Oslo University Hospital
- Investigators
- Øyvind H Lie, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033495
- Sponsor's protocol ID
- 657796
- Acronym
- MICS-Reduce
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We aim to share data upon request from other academic investigators, but await EC approval
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Ischemia by 15O-H2O PET/CT in Patients With Coronary Artery Disease and Refractory Angina - Evaluation of the Coronary Sinus Reduction Stent Method
- ClinicalTrials.gov ID
- NCT06033495
- Acronym / sponsor ID
- MICS-Reduce / 657796
- Conditions
- Angina Pectoris
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- 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.
Chronic angina pectoris refractory to medical and revascularization therapies is a disabling medical condition and a major public health problem. Patients with refractory angina have limited treatment options. One proposed therapy modality is transcatheter implantation of a reduction stent in the coronary sinus. Coronary sinus reduction stents have been shown to reduce angina burden considerably and to improve quality of life. The reduction stent is assumed to increase myocardial perfusion and reduce myocardial ischemia, but the mechanism of action is poorly understood.
The aim of this project is to assess the myocardial ischemia burden in patients with refractory angina who are undergoing a transcatheter coronary sinus reducer procedure. This is a clinical non-randomized self-controlled cohort study with blinded outcome adjudication for changes in myocardial perfusion. Patients with refractory angina will be systematically examined before implantation of the coronary sinus reduction stent and after 6 months. The primary outcome, changes in myocardial perfusion on the gold standard 15O-H2O PET/CT will be evaluated on blinded perfusion scans where the stent is invisible. To provide context to the findings, we will also evaluate whether changes in myocardial ischemia are associated with less angina and better cardiac function parameters. Effects of stent implantation on angina symptoms and quality of life could be affected by a placebo effect.
Treatment options for patients with refractory angina is needed, and results from the present study will explore if coronary sinus reduction stents are improving myocardial ischemia in this patient group. Signs of improved objective perfusion will inspire confidence in the method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with refractory angina undergoing coronary sinus reduction stent implantation | – | Device: Coronary sinus reduction stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease and refractory angina who are under clinical care are informed and screened for participation if consent is provided.
Key inclusion criteria (4 listed)
- Coronary artery disease and refractory angina
- Clinical indication for coronary sinus reduction stent implantation
- Written informed consent
- Anticipated compliance with protocol
Key exclusion criteria (3 listed)
- Ineligibility for coronary sinus reduction stent implantation
- Lack of informed consent
- Not expected to comply with protocol
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 |
|---|---|---|
| Coronary sinus reduction stentPercutaneous stent implantation to reduce the dimension of the coronary sinus | Device | Patients with refractory angina undergoing coronary sinus reduction stent implantation |
Primary outcome
Myocardial ischemia
Time frame: 6 months
Change in myocardial flow reserve on 15O-H2O PET/CT
4 secondary outcomes
Change in angina burden
Time frame: 6 months
Change in quality of life
Time frame: 6 months
Change in exercise capacity
Time frame: 6 months
Change in coronary microcirculation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Undecided. We aim to share data upon request from other academic investigators, but await EC approval
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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.
Øyvind H Lie principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Pectoris, run by Oslo University Hospital.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Øyvind Lie, MD, PhD (+4793429011, oyvlie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial ischemia (time frame: 6 months). 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 21 Sep 2023.