- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06951100
Mechanisms of Myocardial Injury and Ischemia in Patients With Rapid Atrial Fibrillation (Mi-AF)
The goal of this observational study is to better understand the role of measuring troponin (a protein measured by a blood test) and coronary imaging in patients presenting with rapid atrial fibrillation (AF)
The main questions this study aims to answer are:
- Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) more likely than those without damage to the heart to have blocked heart arteries (obstructive coronary artery disease)
- Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) with further evidence that their heart hasn't been getting enough oxygen (myocardial ischemia) more likely to have imaging evidence of myocardial infarction than those without myocardial ischemia
To do this, we will measure troponin in patients with rapid AF and then carry out further investigations of the heart (electrocardiogram, echocardiogram, CT scan and cardiac MRI)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
East Of England
-
Edinburgh, East Of England, United Kingdom
- Recruiting
- Royal Infirmary of Edinburgh
-
Contact:
- Elizabeth Highton-Williamson
- Phone Number: 0131 242 6431
- Email: ehighton@ed.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years and over
- Primary presentation with symptoms related to atrial fibrillation
- Atrial fibrillation with a ventricular rate >100 bpm on a 12-lead electrocardiogram
- Able to provide informed consent
Exclusion Criteria
- Previous myocardial infarction
- Previous coronary revascularisation procedure
- Patients in renal failure (eGFR <30ml/min/1.73m2) or major allergy to contrast media
- Pregnancy or breast feeding
- Deemed unsuitable for participation in the study by the attending clinician
- Previous enrolment in the trial
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of obstructive coronary artery disease
Time Frame: within 4 weeks of presentation
|
Presence of obstructive coronary artery disease as defined as at least one stenosis ≥70% in a major epicardial coronary artery or ≥50% in the left main stem on CTCA or invasive coronary angiography
|
within 4 weeks of presentation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Imaging evidence of new myocardial infarction
Time Frame: within 4 weeks of presentation
|
Imaging evidence of new myocardial infarction
|
within 4 weeks of presentation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- AC24081
- 25-SS-0009 (Other Identifier: Health Research Authority (HRA))
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation (AF)
-
Abbott Medical DevicesRecruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Paroxysmal AFSpain, Belgium, Czechia, Denmark, Germany, Ireland, Italy, Lithuania, Poland
-
Arga Medtech SARecruitingAtrial Fibrillation (AF) | Paroxysmal AF | Persistant Atrial FibrillationUnited States, Netherlands, Croatia, Belgium, Lithuania, Czechia
-
Boston Scientific CorporationRecruitingLeft Atrial Appendage Closure | Non-valvular Atrial Fibrillation (AF)Spain, Germany, Denmark, Switzerland, Italy
-
Boston Scientific CorporationCompleted
-
Boston Scientific CorporationRecruitingAtrial Fibrillation (AF) | Persistant Atrial FibrillationUnited States, Spain, Belgium, France, Netherlands, Germany, Hong Kong
-
Medtronic Cardiac Ablation SolutionsRecruitingParoxysmal Atrial Fibrillation (PAF) | Persistent Atrial Fibrillation | Atrial Fibrillation (AF)Australia, United States, France, Belgium, Switzerland, Czechia
-
Navy General Hospital, BeijingNot yet recruitingAtrial Fibrillation (AF) | Atrial Fibrillation Burden
-
VZW Cardiovascular Research Center AalstBiosense Webster, Inc.RecruitingAtrial Fibrillation (AF) | Paroxysmal AFBelgium
-
Gødstrup HospitalUniversity of AarhusNot yet recruitingAtrial Flutter | Atrial Fibrillation (AF)Denmark
-
Vital Audio IncMinneapolis Heart Institute FoundationNot yet recruitingAtrial Flutter | Atrial Fibrillation (AF)
Clinical Trials on CT coronary angiography
-
St. Olavs HospitalNorwegian University of Science and Technology; Helse Nord-Trøndelag HF; Alesund... and other collaboratorsActive, not recruitingNon-ST Elevated Myocardial InfarctionNorway
-
University Hospital of PatrasCompletedCoronary Artery Bypass SurgeryGreece
-
Assiut UniversityCompleted
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingPulmonary Arterial HypertensionItaly
-
University Medical Centre LjubljanaCompletedHeart Transplant Failure | VasculopathySlovenia
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Recruiting
-
Shanghai Zhongshan HospitalActive, not recruiting
-
Seoul National University HospitalOdense University Hospital; University of British Columbia; Aarhus University... and other collaboratorsActive, not recruitingAcute Myocardial Infarction | Unstable AnginaKorea, Republic of
-
Johns Hopkins UniversityCanon Medical Systems, USACompletedCoronary Artery DiseaseUnited States
-
Samsung Medical CenterRecruitingCoronary Artery Disease | Ischemic Heart DiseaseSouth Korea