CMR in T2DM: The NSR Cohort

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Næstved/Slagelse/Ringsted Cohort

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05915260
• Other study ID #: SJ-992
• Status: Enrolling by invitation
• Start date: April 1, 2023
• Est. completion date: January 31, 2030

Study information

• Verified date: June 2023
• Source: Slagelse Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 700
• Est. completion date: January 31, 2030
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiovascular Magnetic Resonance Imaging
• Coronary Microvascular Dysfunction
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Cardiomyopathies

Intervention

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

Locations

Country	Name	City	State
Denmark	Slagelse Hospital, department of cardiology and endocrinology, medicine 2	Slagelse

Sponsors (2)

Lead Sponsor	Collaborator
Slagelse Hospital	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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	Using multivariable regression including age, sex, smoking, Hypertension, HbA1c, CRP, blood pressure, albuminuria, autonomic neuropathy, retinopathy factors associated with either progression or regression of diabetic cardiomyopathy will be tested. Progression of diabetic cardiomyopathy will be defined as increasing myocardial extracellular volume, decreasing myocardial perfusion reserve, decreasing strain (GLS, GCS, GRS), increasing E/e´compared to baseline.	5 years follow-up