Status:

UNKNOWN

Imaging vs. no Testing in Asymptomatic High-risk Diabetic Patients

Lead Sponsor:

Clinical Centre of Serbia

Conditions:

Asymptomatic

High Risk

Eligibility:

All Genders

30-80 years

Phase:

NA

Brief Summary

The aim of our study was to evaluate 1- and 3-year outcome of alternative imaging strategies in asymptomatic high-risk diabetic patients: functional stress echocardiography combined with coronary flow...

Detailed Description

A meta-analysis of \>100 prospective studies, showed that diabetes mellitus (DM) in general carries a two-fold excess risk of vascular outcomes (coronary artery disease, ischemic stroke, and vascular ...

Eligibility Criteria

Inclusion

  • Asymptomatic patients (\>30 years) with duration of diabetes ≥10 years without target organ damage plus any other additional risk factor including age, hypertension, dyslipidemia, smoking, and obesity.

Exclusion

  • Patient categorized as very high or moderate risk for CV diseases
  • Any symptoms suggestive of angina or heart failure
  • Patients with baseline ECG or echo abnormalities
  • Patients with known CV disease, or previous myocardial revascularization
  • Patients with target organ damage defined as proteinuria, renal impairment defined as eGFR \<30 mL/min/1.73 m2, left ventricular hypertrophy, or retinopathy

Key Trial Info

Start Date :

January 28 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT04388280

Start Date

January 28 2021

End Date

December 31 2023

Last Update

August 18 2021

Active Locations (1)

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Clinical Centre of Serbia

Belgrade, Serbia, 11000