MINOCANCT05681858
Plaque Burden and Ischemia in MINOCA
An observational study of MINOCA, run by University of Bergen at 1 site in Norway.
Trial summary
The goal of this clinical trial is to assess coronary artery plaque burden, perivascular inflammation and extent of myocardial ischemia in patients presenting with acute myocardial infarction and non-obstructive coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MINOCA
- What is being tested?
- CT coronary angiography and [12N] NH3 PET-MR
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2023to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized with acute myocardial infarction and non-obstructive coronary artery disease by coronary angiography
Who may be able to join
- Acute chest pain
- Elevated troponin
- Non-obstructive coronary arteries by coronary angiography
Who cannot join
- Obstructive coronary artery disease
- Contraindications against CT coronary angiography or stress [12N] NH3 PET-MR
- Not able to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Department of Clinical Science, University of Bergen
Bergen, 5021
Mai Tone Lønnebakken, MD phd, +47 55972220, mai.lonnebakken@uib.no
Terje H Larsen, MD phd, +4755975000, terje.hjalmar.larsen@helse-bergen.no
About this study
Official title: Coronary Artery Plaque, Perivascular Inflammation and Myocardial Ischemia in Patients With Myocardial Infraction and Non-obstructive Coronary Arteries
The goal of this clinical trial is to assess coronary artery plaque burden, perivascular inflammation and extent of myocardial ischemia in patients presenting with acute myocardial infarction and non-obstructive coronary artery disease. The main question it aims to answer are:
- Identify coronary artery anatomy, plaque burden, composition and high-risk plaque features by CT coronary angiography in MINOCA
- Assess presence, extent and severity of myocardial ischemia in MINOCA
Participants will examined by CT coronary angiography and stress [12N] NH3 PET-MR.
- Conditions
- MINOCA
- Being tested
- CT coronary angiography and [12N] NH3 PET-MR
- Medical subject headings
- MINOCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT coronary angiography and [12N] NH3 PET-MRDiagnostic test
Advanced coronary artery plaque analysis, myocardial ischemia and coronary flow reserve
| Study group | Role | What they receive |
|---|---|---|
| CT coronary angiography and [12N] NH3 PET-MR | All patients will undergo CT coronary angiography and stress [12N] NH3 PET-MR Receives: Diagnostic Test: CT coronary angiography and [12N] NH3 PET-MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque burden
Measured: 1 week
Myocardial ischemia
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start15 Aug 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MINOCAStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Haraldsplass Deaconess Hospital
- Responsible party
- Principal investigator, Mai Tone Lønnebakken, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681858
- Sponsor's protocol ID
- 463549
- Status last verified
- Nov 2023
- First submitted
- 3 Jan 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Plaque, Perivascular Inflammation and Myocardial Ischemia in Patients With Myocardial Infraction and Non-obstructive Coronary Arteries
- ClinicalTrials.gov ID
- NCT05681858
- Acronym / sponsor ID
- 463549
- Conditions
- MINOCA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Haraldsplass Deaconess Hospital
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 12 Jan 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.
The goal of this clinical trial is to assess coronary artery plaque burden, perivascular inflammation and extent of myocardial ischemia in patients presenting with acute myocardial infarction and non-obstructive coronary artery disease. The main question it aims to answer are:
- Identify coronary artery anatomy, plaque burden, composition and high-risk plaque features by CT coronary angiography in MINOCA
- Assess presence, extent and severity of myocardial ischemia in MINOCA
Participants will examined by CT coronary angiography and stress [12N] NH3 PET-MR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT coronary angiography and [12N] NH3 PET-MR | – | Diagnostic Test: CT coronary angiography and [12N] NH3 PET-MRAll patients will undergo CT coronary angiography and stress [12N] NH3 PET-MR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized with acute myocardial infarction and non-obstructive coronary artery disease by coronary angiography
Key inclusion criteria (3 listed)
- Acute chest pain
- Elevated troponin
- Non-obstructive coronary arteries by coronary angiography
Key exclusion criteria (3 listed)
- Obstructive coronary artery disease
- Contraindications against CT coronary angiography or stress [12N] NH3 PET-MR
- Not able to give informed consent
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 |
|---|---|---|
| CT coronary angiography and [12N] NH3 PET-MRAdvanced coronary artery plaque analysis, myocardial ischemia and coronary flow reserve | Diagnostic test | CT coronary angiography and [12N] NH3 PET-MR |
Primary outcome
Plaque burden
Time frame: 1 week
Myocardial ischemia
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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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.
Department of Clinical Science, University of Bergen
Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MINOCA, run by University of Bergen at 1 site in Norway.
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 3 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: looking for participants now, as of the sponsor's last update on 4 Dec 2023. 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 Norway. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque burden (time frame: 1 week). The study lists 2 primary outcomes in all. 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 4 Dec 2023.