- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06966531
- Original Trial
Prevalence of Myocarditis in Patients Suspected Myocardial Infarction With Non-Obstructive Coronary Arteries
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed Gamal Thabit Mohamed
- Phone Number: +201065476011
- Email: ahmedgamal54011@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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%)
Exclusion Criteria:
- Significant coronary artery disease (>50% stenosis) on angiography.
- Prior history of myocarditis or cardiomyopathy.
- Contraindications to CMR (e.g., pacemakers, severe renal dysfunction).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MINOCA
Acute Myocardial infarction patient with non obstructive coronary arteries
|
distinguish between true MI with significant lesion and MINOCA with insignificant lesions (less than 50%)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of myocarditis in patients presenting with MINOCA, as diagnosed by CMR.
Time Frame: 1 years
|
Studying The incidence of myocarditis in MINOCA patients
|
1 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayman khairy Mohamed Hassan, Cardiology Department
- Principal Investigator: Khaled Mohamed Abdullah Mohamed, Cardiology Department
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Myocarditis in MINOCA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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