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NCT05326828Recruiting

Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA

Source: ClinicalTrials.gov · Last updated 30 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Myocardial infarction with non-obstructive coronary arteries (MINOCA) (i.e.\<50% stenoses) on coronary angiography) is an underappreciated clinical entity concerning 5-6% of patients with acute myocardial infarction. Approximately 50% of these patients remain without appropriate diagnosis and treatment. The MINOCA study aims at systematically assessing the frequency of underlying pathologies of MINOCA and outcomes with a multidisciplinary etiologic work-up and follow-up of 5 years including, for the first time, an implantable cardiac monitor (ICM) to assess the frequency of atrial fibrillation as underlying cause for MINOCA.

Status (registry)
Recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
6 Apr 2022
Start date
24 May 2022
Primary completion date
24 May 2026
Lead sponsor
Insel Gruppe AG, University Hospital Bern
NCT number
NCT05326828

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From 24 May 2022 to the primary completion date, 24 May 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous MI
  • Previous percutaneous coronary intervention (PCI)
  • Previous coronary artery bypass grafting (CABG)
  • Previous MI
  • Previous PCI
  • Previous CABG

Other illness

  • History of atrial fibrillation or atrial flutter ablation
  • Known coronary artery disease
  • Known coronary artery disease

Lab values

  • Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, glomerular filtration rate (GFR) \<30 ml/min)
  • Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, GFR \<30 ml/min)

Other

  • Known atrial fibrillation or atrial flutter
  • Contraindications to ICM implantation
  • Clear underlying cause of MINOCA before ICM implantation

Who the study is looking for

  • ≥18 years of age
  • Written informed consent
  • Acute myocardial infarction (AMI) type 1 in accordance with the 4th universal definition of myocardial infarction
  • Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses ≥50% in any potential infarct-related artery
  • No clinically overt specific cause for the acute presentation
  • Subendocardial or transmural late gadolinum enhancement (LGE) consistent with an ischemic etiology on cardiac magnetic resonance imaging (CMR)
  • No clear underlying cause of MINOCA and therefore increased probability of atrial fibrillation
  • ≥18 years of age
  • Written informed consent
  • AMI type 1 in accordance with the 4th universal definition of myocardial infarction
  • Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses ≥50% in any potential infarct-related artery
  • No clinically overt specific cause for the acute presentation
  • Subendocardial or transmural LGE consistent with an ischemic etiology on CMR

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Bern University Hospital, Inselspital
Coordinator of this site? Confirm its status
BernSwitzerlandRecruiting
University Hospital Zurich (USZ)
Coordinator of this site? Confirm its status
ZurichSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.