CMR in T2DM: The NSR Cohort

NCT05915260 | Enrolling By Invitation DMC

• 1 other identifier: SJ-992
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Diabetic Cardiomyopathies; Cardiovascular Magnetic Resonance Imaging; Coronary Microvascular Dysfunction; Myocardium; Fibrosis

Outcome Measures

Primary Outcomes (4)

• Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years

  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

  5 years follow-up

• Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years

  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)

  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

  Myocardial perfusion measured by myocardial blood flow and myocardial perfusion ratio quantified by cardiac MRI.

  Baseline and at 5 years follow-up

• The association of pericardial- and epicardial fat with myocardial function and MACE after 5 year

  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

  Baseline and at 5 years follow-up

Secondary Outcomes (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

  5 years follow-up

Study Arms (2)

Patients with type 2 diabetes

This group will be split up into different groups. DM2 with vs. without complications to diabetes DM2 with vs. without albuminuria/nephropathy or autonomic neuropathy or retinopathy or peripheral neuropathy or macrovascular angiopathy

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

sex and age matched control subjects

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

Interventions

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

This is a observational follow up study accordingly all subjects will undergo the same examinations

Also known as: Echocardiography, medical interview, general medical examination, BP, HR e.g., Examination for non cardiac complications to diabetes

Patients with type 2 diabetes; sex and age matched control subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Few and simple, allowing for a broad cohort.
• Male or female fully capable of providing informed consent
• Informed consent
• Age 18-80 (both included)

Sponsors & Collaborators

• Slagelse Hospital: lead
• Herlev Hospital: collaborator

Study Sites (1)

Slagelse Hospital, department of cardiology and endocrinology, medicine 2

Slagelse, 4200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Cardiomyopathies; Fibrosis

Interventions

Echocardiography; Physical Examination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Diabetes Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 22, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2030
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

DK (1)