CMR in T2DM: The NSR Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies, Cardiovascular Magnetic Resonance Imaging, Coronary Microvascular Dysfunction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Næstved/Slagelse/Ringsted Cohort
Overview
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.
Interventions
- Diagnostic test All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion
This is a observational follow up study accordingly all subjects will undergo the same examinations
Primary outcome measures
- Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years [Time frame: 5 years follow-up]
- Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years [Time frame: 5 years follow-up]
- Impact of myocardial perfusion and cardiac cardiac output on perfusion in other organs (kidney, spleen, liver) assed by gadolinium contrast magnetic resonance imaging [Time frame: Baseline and at 5 years follow-up]
- The association of pericardial- and epicardial fat with myocardial function and MACE after 5 year [Time frame: Baseline and at 5 years follow-up]
Secondary outcome measures (1)
- 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 [Time frame: 5 years follow-up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Slagelse Hospital, department of cardiology and endocrinology, medicine 2 — Slagelse
Identifiers
NCT: NCT05915260 · SJ-992