ESC working group position paper on myocardial infarction with non-obstructive coronary arteries.
Stefan Agewall, John F Beltrame, Harmony R Reynolds...
https://pubmed.ncbi.nlm.nih.gov/28158518Actively Recruiting
Age: 18Years - 85Years
All Genders
ID05326828
Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-10-30
60
Participants Needed
2
Research Sites
259 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
U
University Hospital, Zürich
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying myocardial infarction with non-obstructive coronary arteries (MINOCA), a condition affecting about 5-6% of patients with acute myocardial infarction. Many patients with MINOCA remain without a proper diagnosis or treatment. This study aims to systematically identify underlying causes of MINOCA and track patient outcomes over five years, including the use of an implantable cardiac monitor (ICM) to detect atrial fibrillation as a potential cause of MINOCA. Participants are divided into two groups: those eligible for ICM implantation and those ineligible due to refusal, contraindications, or a known cause of MINOCA. The ICM group will receive the CONFIRM Rx implantable cardiac rhythm monitor, while both groups undergo a thorough diagnostic work-up including imaging and tests such as intracoronary optical coherence tomography, cardiac magnetic resonance imaging, transesophageal echocardiography, vasospasm testing, thrombophilia screening, and Holter ECG (non-ICM group only). During the study, participants will be closely monitored for occurrences of atrial fibrillation and other cardiac events through the ICM and diagnostic tests. Researchers will assess outcomes including time to atrial fibrillation diagnosis, atrial fibrillation burden, stroke, death, and other arrhythmias over several years. Clinical outcomes will be followed for five years to better understand MINOCA causes and patient health. The study includes regular evaluations and data collection to support comprehensive long-term monitoring.
CONDITIONS
Brief Title
Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Written informed consent
- Diagnosed with acute myocardial infarction (AMI) type 1 according to the 4th universal definition
- Non-obstructive coronary arteries on angiography with less than 50% stenosis in any artery
- No clear specific cause identified for the acute event
- Subendocardial or transmural late gadolinium enhancement consistent with ischemic cause on cardiac magnetic resonance imaging (CMR)
- For ICM group: No clear cause of MINOCA and increased probability of atrial fibrillation
You will not qualify if you...
- Known atrial fibrillation or atrial flutter
- History of atrial fibrillation or atrial flutter ablation
- Known coronary artery disease
- Previous myocardial infarction
- Previous percutaneous coronary intervention (PCI)
- Previous coronary artery bypass grafting (CABG)
- Contraindications to cardiac magnetic resonance imaging (e.g., non-MR-compatible device, low kidney function with GFR <30 ml/min)
- Contraindications to implantable cardiac monitor implantation
- Clear underlying cause of MINOCA before ICM implantation (for ICM group)
AI-Screening
AI-Powered Screening
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1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Diagnostic Evaluation
Duration - Up to 1 year
Participants undergo a systematic etiologic work-up including tests like intracoronary optical coherence tomography, cardiac magnetic resonance imaging, transesophageal echocardiography, vasospasm testing, thrombophilia screening, and Holter ECG (only for the non-implantable cardiac monitor group) to investigate underlying causes of MINOCA.
Visits as needed for diagnostic tests
Implementation
Duration - Up to approximately 2 years (battery end of life or explantation)
Participants eligible for implantable cardiac monitor (ICM) implantation receive the CONFIRM Rx implantable cardiac rhythm monitor to detect atrial fibrillation.
Visits for device implantation and monitoring according to protocol
Long-term Monitoring
Duration - 5 years
Participants are followed for clinical outcomes and monitoring of atrial fibrillation and other cardiac events over a period of 5 years.
Follow-up visits over 5 years
Trial Site Locations
Total: 2 locations
1
Bern University Hospital Inselspital
Bern, Switzerland, 3010
Actively Recruiting
2
University Hospital Zurich USZ
Zurich, Switzerland, 8091
Actively Recruiting
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Research Team
L
Lorenz Räber, MD, PhD
S
Sarah Bär, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Contemporary Diagnosis and Management of Patients With Myocardial Infarction in the Absence of Obstructive Coronary Artery Disease: A Scientific Statement From the American Heart Association.
Jacqueline E Tamis-Holland, Hani Jneid, Harmony R Reynolds...
https://pubmed.ncbi.nlm.nih.gov/30913893Comprehensive Evaluation of Rhythm Monitoring Strategies in Screening for Atrial Fibrillation: Insights From Patients at Risk Monitored Long Term With an Implantable Loop Recorder.
Søren Zöga Diederichsen, Ketil Jørgen Haugan, Christian Kronborg...
https://pubmed.ncbi.nlm.nih.gov/321147962020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC.
Gerhard Hindricks, Tatjana Potpara, Nikolaos Dagres...
https://pubmed.ncbi.nlm.nih.gov/32860505Mortality of Myocardial Infarction by Sex, Age, and Obstructive Coronary Artery Disease Status in the ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines).
Nathaniel R Smilowitz, Asha M Mahajan, Matthew T Roe...
https://pubmed.ncbi.nlm.nih.gov/29246884Systematic review of patients presenting with suspected myocardial infarction and nonobstructive coronary arteries.
Sivabaskari Pasupathy, Tracy Air, Rachel P Dreyer...
https://pubmed.ncbi.nlm.nih.gov/25587100Myocardial Infarction Without Obstructive Coronary Artery Disease is Not a Benign Condition (ANZACS-QI 10).
Peter R Barr, Wil Harrison, David Smyth...
https://pubmed.ncbi.nlm.nih.gov/28408093Presentation, Clinical Profile, and Prognosis of Young Patients With Myocardial Infarction With Nonobstructive Coronary Arteries (MINOCA): Results From the VIRGO Study.
Basmah Safdar, Erica S Spatz, Rachel P Dreyer...
https://pubmed.ncbi.nlm.nih.gov/29954744Myocardial infarction with nonobstructive coronary arteries: a single-center retrospective study.
Fernando Montenegro Sá, Catarina Ruivo, Luís G Santos...
https://pubmed.ncbi.nlm.nih.gov/29608443Myocardial infarction with non-obstructive coronary arteries (MINOCA) in Chinese patients: Clinical features, treatment and 1 year follow-up.
Fuad A Abdu, Lu Liu, Abdul-Quddus Mohammed...
https://pubmed.ncbi.nlm.nih.gov/30826195