The Cardio-Metabolic Clinic
Cardiovascular Protection in Patients With Type 2 Diabetes and Established Heart or Vascular Disease - The Cardio-Metabolic Clinic
Odense University Hospital
1,600 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria14
- \>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
Exclusion Criteria3
- Life expectancy less than 5 years for any reason
- Type 1 Diabetes Mellitus
- Participation in another clinical trial with an investigational product or device that could interfere with the primary and/or secondary endpoints of this study
Interventions
The Cardio-Metabolic Clinic will adhere to a standardized evaluation and treatment program based on the latest treatment guidelines from the European Cardiovascular Society. The assessment will include the following points: * Lipid management * Blood pressure management * Antithrombotic therapy * Glycemic targets * Prevention of diabetes-related complications * Treatment of vascular disease affecting the lower extremities * Evaluation of cardioprotective drugs * Counseling on lifestyle factors, including diet, smoking, alcohol, and exercise * Guidance on vaccinations
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06203860