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RECRUITINGINTERVENTIONAL

The Cardio-Metabolic Clinic

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Inclusion: - \>18 years - Capable of giving written willing to sign a consent form - Established diagnosis of T2D - Having established heart or vascular disease defined as either: - Atherosclerotic disease defined as: 1. Prior acute coronary syndrome (ACS). 2. 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. 3. Stroke. 4. Peripheral arterial disease (PAD) defined as: Claudication intermittence in combination with pathological ABI AND/OR vascular PAD surgery AND/OR ischemic amputation. 5. 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: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion: * \>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: 1. Prior acute coronary syndrome (ACS). 2. 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. 3. Stroke. 4. Peripheral arterial disease (PAD) defined as: Claudication intermittence in combination with pathological ABI AND/OR vascular PAD surgery AND/OR ischemic amputation. 5. 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: * 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

Treatments Being Tested

OTHER

Cardio-Metabolic Clinic

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)

Cardiovascular Research Unit, Odense University Hospital - Svendborg
Svendborg, Region Syddanmark, Denmark