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
Study 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
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Time to first occurrence of major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, and hospitalisation for heart failure (HF). — From baseline to 5 years of follow-up Measured in days.
Trial sites (1)
Facility
City
Region
Status
Cardiovascular Research Unit, Odense University Hospital - Svendborg
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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