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Enrolling by invitation Observational

CMR in T2DM: The NSR Cohort

NCT05915260 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2023-04-01
Last updated
2023-06-22

Condition(s) studied

Diabetes Mellitus, Type 2Diabetic CardiomyopathiesCardiovascular Magnetic Resonance ImagingCoronary Microvascular DysfunctionMyocardium; Fibrosis

Investigational drug(s) / intervention(s)

All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion

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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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 outcome measure(s)

  • Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years — 5 years follow-up
    Myocardial microvascular function is measured by the myocardial perfusion ratio, quantified by cardiac MRI. MACE defined as CVD events (AMI, HF, stable angina, atrial fibrillation, ventricular arytmia), stroke, death
  • Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years — 5 years follow-up
    Clinical factors :Albuminuria, autonomic neuropathy, retinopathy, HbA1c, hs-CRP. Signs of worsening af diabetic cardiomyopathy: Increased myocardial extracellular volume, decreased myocardial blood flow and myocardial perfusion reserve, decreased strain (GLS; GCS, GRS), increasing E/e´, increasing concentri remodeling index(LV mass / LV end-diastolic volume)
  • Impact of myocardial perfusion and cardiac cardiac output on perfusion in other organs (kidney, spleen, liver) assed by gadolinium contrast magnetic resonance imaging — Baseline and at 5 years follow-up
    Myocardial perfusion measured by myocardial blood flow and myocardial perfusion ratio quantified by cardiac MRI.
  • The association of pericardial- and epicardial fat with myocardial function and MACE after 5 year — Baseline and at 5 years follow-up
    Myocardial function: LVEF, LV strain (GLS, GCS, GRS), E/e´, myocardial extracellular volume, myocardial perfusion ratio. MACE defined as CVD events (AMI, HF, stable angina, atrial fibrillation, ventricular arytmia), stroke, death

Trial sites (1)

FacilityCityRegionStatus
Slagelse Hospital, department of cardiology and endocrinology, medicine 2 Slagelse Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05915260 on ClinicalTrials.gov ↗ ← All trials in Denmark