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CMR in T2DM: The NSR Cohort

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ClinicalTrials.gov Identifier: NCT05915260
Recruitment Status : Enrolling by invitation
First Posted : June 22, 2023
Last Update Posted : June 22, 2023
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Slagelse Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Diabetic Cardiomyopathies Cardiovascular Magnetic Resonance Imaging Coronary Microvascular Dysfunction Myocardium; Fibrosis Diagnostic Test: All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion

Study Design
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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Næstved/Slagelse/Ringsted Cohort
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : January 31, 2030

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
This is a observational follow up study accordingly all subjects will undergo the same examinations
Other Names:
  • Echocardiography
  • medical interview
  • general medical examination, BP, HR e.g.
  • Examination for non cardiac complications to diabetes
sex and age matched control subjects 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
Other Names:
  • Echocardiography
  • medical interview
  • general medical examination, BP, HR e.g.
  • Examination for non cardiac complications to diabetes


Outcome Measures
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Primary Outcome Measures :
  1. Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years [ Time Frame: 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

  2. Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years [ Time Frame: 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)


  3. 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 ]
    Myocardial perfusion measured by myocardial blood flow and myocardial perfusion ratio quantified by cardiac MRI.

  4. The association of pericardial- and epicardial fat with myocardial function and MACE after 5 year [ Time Frame: 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



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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05915260


Locations
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Denmark
Slagelse Hospital, department of cardiology and endocrinology, medicine 2
Slagelse, Denmark, 4200
Sponsors and Collaborators
Slagelse Hospital
Herlev Hospital
More Information
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Responsible Party: Slagelse Hospital
ClinicalTrials.gov Identifier: NCT05915260    
Other Study ID Numbers: SJ-992
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: June 22, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On request and with the proper approvals
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Diabetic Cardiomyopathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Diabetes Complications
Adenosine
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action