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The Cardio-Metabolic Clinic

RECRUITINGN/ASponsored by Odense University Hospital
Actively Recruiting
PhaseN/A
SponsorOdense University Hospital
Started2024-01-01
Est. completion2029-05-01
Eligibility
Age19 Years+
Healthy vol.Accepted

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

Age: 19 Years+Healthy volunteers accepted
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

Conditions4

Cardiovascular DiseasesDiabetesDiabetes Mellitus, Type 2Heart Disease

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