Prevalence of Myocarditis in MINOCA PatientsNCT06966531
Prevalence of Myocarditis in Patients Suspected Myocardial Infarction With Non-Obstructive Coronary Arteries
An observational study of Prevalence of Myocarditis in MINOCA Patients, run by Assiut University.
Trial summary
This study aims to determine the prevalence of myocarditis among patients suspected of having myocardial infarction with non-obstructive coronary arteries (MINOCA) and to analyze its clinical characteristics, diagnostic markers . Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Prevalence of Myocarditis in MINOCA Patients
- What is being tested?
- Coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2025to 1 Apr 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 17 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Study Population Description Myocardial infarction patients who were underwent PPCI and the coronary angiography showing insignificant lesions (stenosis less than 50% )
Who may be able to join
- All patients; diagnosed with myocardial infarction with nonobstructive coronary arteries (MINOCA)
- clinical symptoms
- ECG : ischemic changes with or without ST segment elevation
- Echocardiograpy : segmental wall motion abnormalities (SWMA)
- positive cardiac enzymes
- Coronary angiography: insignificant lesions ,the absence of culprit obstructive coronary artery disease (epicardial coronary artery stenosis ≥50%)
Who cannot join
- Significant coronary artery disease (>50% stenosis) on angiography.
- Prior history of myocarditis or cardiomyopathy.
- Contraindications to CMR (e.g., pacemakers, severe renal dysfunction).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to determine the prevalence of myocarditis among patients suspected of having myocardial infarction with non-obstructive coronary arteries (MINOCA) and to analyze its clinical characteristics, diagnostic markers .
Read the detailed description
Acute myocardial infarction (AMI) remains the leading causes of high morbidity and mortality worldwide, Recently, a distinct population with myocardial infarction with nonobstructive coronary arteries (MINOCA) has been increasingly recognized because of the widespread use of coronary angiography. MINOCA occurs in 5%-10% of all AMI and they are younger and more often women compared to patients with AMI and obstructive coronary artery disease (CAD) , The underlying causes of MINOCA are manifold and may include plaque rupture or erosion, thromboembolism, coronary spasm, spontaneous dissection, microvascular dysfunction and supply/demand mismatch. Some non-ischemic diseases such as myocarditis may also mimic the presentation of MINOCA .Of note, several studies have found that the prognosis of MINOCA is not trivial and patients are still at considerable risks for long-term adverse cardiovascular (CV) events despite the optimal secondary prevention treatments [[6], [7], [8], [9], [10]]. Thus, it is of necessity and profound implications to find potential residual risk factors and improve prognosis in MINOCA population.
Myocarditis is commonly caused by viral infections, but it can also be caused by bacterial infections, toxic substances, or autoimmune disorders . Myocarditis is more common in younger patients, although it affects patients of all ages. Fulminant myocarditis, although rare, can result in life-threatening cardiogenic shock . Diagnosis of myocarditis is made using CMRI characterized by the presence of diffuse myocardial edema on T2 and with myocardial biopsy . In a meta-analysis of five observational studies with available CMRI data, one-third of MINOCA patients had myocarditis. It was more common in younger patients and those with high C-reactive protein .
- Being tested
- Coronary angiography
- Keywords
- Myocarditis, MINOCA, Normal coronary angiography
- Medical subject headings
- Myocarditis, MINOCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiographyProcedure or surgery
distinguish between true MI with significant lesion and MINOCA with insignificant lesions (less than 50%)
| Study group | Role | What they receive |
|---|---|---|
| MINOCA | Acute Myocardial infarction patient with non obstructive coronary arteries Receives: Procedure: Coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of myocarditis in patients presenting with MINOCA, as diagnosed by CMR.
Studying The incidence of myocarditis in MINOCA patients
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2025
- Study start5 May 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevalence of Myocarditis in MINOCA PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Retrospective
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Thabit Mohamed, Assiut University
- Investigators
- Ayman khairy Mohamed Hassan, Principal investigator, Cardiology departmentKhaled Mohamed Abdullah Mohamed, Principal investigator, Cardiology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966531
- Sponsor's protocol ID
- Myocarditis in MINOCA
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 12 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Myocarditis in Patients Suspected Myocardial Infarction With Non-Obstructive Coronary Arteries
- ClinicalTrials.gov ID
- NCT06966531
- Acronym / sponsor ID
- Myocarditis in MINOCA
- Keywords
- Myocarditis, MINOCA, Normal coronary angiography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 12 May 2025 (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.
This study aims to determine the prevalence of myocarditis among patients suspected of having myocardial infarction with non-obstructive coronary arteries (MINOCA) and to analyze its clinical characteristics, diagnostic markers .
Detailed description
Acute myocardial infarction (AMI) remains the leading causes of high morbidity and mortality worldwide, Recently, a distinct population with myocardial infarction with nonobstructive coronary arteries (MINOCA) has been increasingly recognized because of the widespread use of coronary angiography. MINOCA occurs in 5%-10% of all AMI and they are younger and more often women compared to patients with AMI and obstructive coronary artery disease (CAD) , The underlying causes of MINOCA are manifold and may include plaque rupture or erosion, thromboembolism, coronary spasm, spontaneous dissection, microvascular dysfunction and supply/demand mismatch. Some non-ischemic diseases such as myocarditis may also mimic the presentation of MINOCA .Of note, several studies have found that the prognosis of MINOCA is not trivial and patients are still at considerable risks for long-term adverse cardiovascular (CV) events despite the optimal secondary prevention treatments [[6], [7], [8], [9], [10]]. Thus, it is of necessity and profound implications to find potential residual risk factors and improve prognosis in MINOCA population.
Myocarditis is commonly caused by viral infections, but it can also be caused by bacterial infections, toxic substances, or autoimmune disorders . Myocarditis is more common in younger patients, although it affects patients of all ages. Fulminant myocarditis, although rare, can result in life-threatening cardiogenic shock . Diagnosis of myocarditis is made using CMRI characterized by the presence of diffuse myocardial edema on T2 and with myocardial biopsy . In a meta-analysis of five observational studies with available CMRI data, one-third of MINOCA patients had myocarditis. It was more common in younger patients and those with high C-reactive protein .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MINOCA | – | Procedure: Coronary angiographyAcute Myocardial infarction patient with non obstructive coronary arteries |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Study Population Description Myocardial infarction patients who were underwent PPCI and the coronary angiography showing insignificant lesions (stenosis less than 50% )
Key inclusion criteria (6 listed)
- All patients; diagnosed with myocardial infarction with nonobstructive coronary arteries (MINOCA)
- clinical symptoms
- ECG : ischemic changes with or without ST segment elevation
- Echocardiograpy : segmental wall motion abnormalities (SWMA)
- positive cardiac enzymes
Key exclusion criteria (3 listed)
- Significant coronary artery disease (>50% stenosis) on angiography.
- Prior history of myocarditis or cardiomyopathy.
- Contraindications to CMR (e.g., pacemakers, severe renal dysfunction).
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 angiographydistinguish between true MI with significant lesion and MINOCA with insignificant lesions (less than 50%) | Procedure or surgery | MINOCA |
Primary outcome
Prevalence of myocarditis in patients presenting with MINOCA, as diagnosed by CMR.
Time frame: 1 years
Studying The incidence of myocarditis in MINOCA patients
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 12 May 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Ayman khairy Mohamed Hassan principal investigator
Cardiology department
Khaled Mohamed Abdullah Mohamed principal investigator
Cardiology department
Questions about this trial
What is this clinical trial studying?
An observational study of Prevalence of Myocarditis in MINOCA Patients, run by Assiut University.
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 6 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: opening soon, as of the sponsor's last update on 12 May 2025. 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?
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?
Contact Ahmed Gamal Thabit Mohamed (+201065476011, ahmedgamal54011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of myocarditis in patients presenting with MINOCA, as diagnosed by CMR. (time frame: 1 years). 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 12 May 2025.