Cardiovascular Protection in Patients With Type 2 Diabetes and Established Heart or Vascular Disease - The Cardio-Metabolic Clinic

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to investigate whether a Cardio-Metabolic Clinic can protect the cardiovascular health of patients with both diabetes and cardiovascular disease. * At the Cardio-Metabolic Clinic, patients will receive a specialized and comprehensive care. This includes applying a systematic approach, considering their whole health based on the latest knowledge in the field, and administering aggressive treatment with heart protective medications. * The ProtecT-2-D trial will compare the effects of care at the Cardio-Metabolic Clinic to usual care to see if there are any differences in cardiovascular illness and death.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• \>18 years

• Capable of giving written informed consent

• Established diagnosis of T2D

• Having established heart or vascular disease defined as either:

• Atherosclerotic disease defined as:

‣ Prior acute coronary syndrome (ACS).

⁃ Chronic coronary syndrome defined as the combination of: Angina pectoris AND coronary atherosclerosis assessed with either Coronary CT angiography (CTA) or Myocardial-scintigraphy (MPI) or Coronary angiography (CAG) AND treatment with statins and/or acetylsalicylic acid.

⁃ Stroke.

⁃ Peripheral arterial disease (PAD) defined as: Claudication intermittence in combination with pathological ABI AND/OR vascular PAD surgery AND/OR ischemic amputation.

⁃ Ischemic heart disease defined by one of the following criteria: a) Myocardial-scintigraphy: \>10% reversibility OR b) Coronary CT angiography: Coronary Artery Calcium (CAC)-score \>100.

• Heart failure (HF): HF with reduced ejection fraction (HFrEF), HF with Mildly reduced ejection fraction (HFmrEF), HF with preserved ejection fraction (HFpEF)

• Atrial fibrillation and/or flutter, including paroxysmal, persistent and chronic disease

• Valvular heart disease (which requires control in outpatient clinic of cardiology), such as aortic valve stenosis, mitral valve insufficiency, and patients with aortic dilatation

• Hypertension treated with at least three antihypertensive drugs

Locations
Other Locations
Denmark
Cardiovascular Research Unit, Odense University Hospital - Svendborg
RECRUITING
Svendborg
Contact Information
Primary
Soeren Auscher, M.D, Ph.D
Soeren.Auscher@rsyd.dk
+45 6320 2402
Backup
Katrine S. Overgaard, M.D
katrine.schultz.overgaard@rsyd.dk
+45 40949749
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2034-05-01
Participants
Target number of participants: 1600
Treatments
Active_comparator: The Cardio-Metabolic Clinic
Comprising specialized, multidisciplinary management of diabetes and cardiovascular disease in a Cardio-Metabolic Clinic.
No_intervention: Usual Care
Involving collaboration between the general practitioner, and/or the endocrinology outpatient clinic, and/or cardiology outpatient clinic.
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital

This content was sourced from clinicaltrials.gov