Clinical trial NCT05915260: CMR in T2DM: The NSR Cohort
Official title: Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Næstved/Slagelse/Ringsted Cohort
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diabetes Mellitus, Type 2
Diabetic Cardiomyopathies
Cardiovascular Magnetic Resonance Imaging
Coronary Microvascular Dysfunction
Myocardium; Fibrosis
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2023-06-22
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Unable to give informed consent
* Absolute contraindications to CMR
* Severe claustrophobia
* Type 1 diabetes mellitus
* More than trivial paroxysmal atrial fibrillation, i.e. persistent or permanent atrial fibrillation
* Women of childbearing potential not on acceptable contraception
* Contraindications to adenosine, e.g. 2nd or 3rd degree AV-block, severe hypotension, long QT-syndrome, unstable angina pectoris, sinus node dysfunction, decompensated heart failure

Brief summary: This study aims to investigate the myocardial phenotype of patients with type 2 diabetes. From 2016-2019 the investigators recruited a cohort of 296 subjects with type 2 diabetes. All subjects underwent clinical examinations including a gadolinium contrast cardiac MRI.

The current study is a clinical follow-up study of the subjects, thus, the investigators will invite all participants to a reevaluation with cardiac MRI.

Additionally, the investigators will aim at recruiting additionally 400 patients with type 2 diabetes.

The aim it to characterize the phenotype of diabetic cardiomyopathy. Uniquely using cardiac MRI we can measure myocardial microvascular function, myocardial localised and diffuse fibrosis in addition to the quantification of myocardial structure and systolic and diastolic function.


Eligibility criteria: Inclusion Criteria:

Few and simple, allowing for a broad cohort.

* Male or female fully capable of providing informed consent
* Informed consent
* Age 18-80 (both included)
* T2DM diagnosed at least 3 months prior to inclusion in the study

Exclusion Criteria:

Primary outcomes:
measure: Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years
timeFrame: 5 years follow-up
measure: Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years
timeFrame: 5 years follow-up
measure: Impact of myocardial perfusion and cardiac cardiac output on perfusion in other organs (kidney, spleen, liver) assed by gadolinium contrast magnetic resonance imaging
timeFrame: Baseline and at 5 years follow-up
measure: The association of pericardial- and epicardial fat with myocardial function and MACE after 5 year
timeFrame: Baseline and at 5 years follow-up
Secondary outcomes:
measure: Characterization of the progression of diabetic cardiomyopathy over 5 years, including LV+RV function, the coronary microvascular function, the coronary macrovascular function, fibrosis, aortic stiffness, per and epicardial fat, perfusion of other organs
timeFrame: 5 years follow-up
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Slagelse Hospital, department of cardiology and endocrinology, medicine 2
Study officials:
References: