Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT05326828
Status:
RECRUITING
Last Update Posted:
2024-10-30
First Post:
2022-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Sponsor:
Insel Gruppe AG, University Hospital Bern
Organization:
Study Overview
Official Title:
Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINOCA
Brief Summary:
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.
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.
Detailed Description:
Approximately 5-6% of patients with acute myocardial infarction (AMI) have myocardial infarction with non-obstructive coronary arteries (MINOCA) (i.e.\<50% stenoses) on coronary angiography and up to 50% of these patients remain without appropriate diagnosis and treatment. A multidisciplinary etiologic work-up of MINOCA has recently been proposed by international consensus documents. The present study aims for a structured scientific data collection from a full guideline-based work-up after MINOCA and follow-up of 5 years to assess clinical outcomes.
Untreated atrial fibrillation is a potentially neglected underlying cause of MINOCA. As implantable cardiac monitors (ICM) can detect atrial fibrillation with high accuracy, the aim of this study is, for the first time, to assess the occurrence of first diagnosed atrial fibrillation with the use of ICM in patients with MINOCA.
To allow for an all-comers data collection, patients with contraindication(s) to ICM implantation will be enrolled into the non-ICM group to assess the frequency of underlying causes of MINOCA and clinical outcomes throughout 5 years.
Untreated atrial fibrillation is a potentially neglected underlying cause of MINOCA. As implantable cardiac monitors (ICM) can detect atrial fibrillation with high accuracy, the aim of this study is, for the first time, to assess the occurrence of first diagnosed atrial fibrillation with the use of ICM in patients with MINOCA.
To allow for an all-comers data collection, patients with contraindication(s) to ICM implantation will be enrolled into the non-ICM group to assess the frequency of underlying causes of MINOCA and clinical outcomes throughout 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: