Status:
UNKNOWN
Metformin in Diabetic Patients Undergoing Coronary Angiography
Lead Sponsor:
Humanitas Hospital, Italy
Conditions:
Diabetes Mellitus
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The present study aims to evaluate the strict application of the 2018 European Society of Cardiology guidelines on myocardial revascularization, that recommends to check renal function if patients hav...
Detailed Description
The study is designed as an open-label (both physician and participant know that metformin will not be discontinued before PCI and in the following 48 hours), prospective, single arm study. In our hi...
Eligibility Criteria
Inclusion
- Diabetic patients treated with metformin undergoing coronary angiography.
Exclusion
- Known coronary anatomy with planned complex percutaneous coronary intervention with high probability of large amount of contrast use (3.7 \* estimated glomerular filtration rate; e.g.: 167 ml in a patients with an eGFR of 45 ml/min/1.73m2).
- Moderate to severe impairment of renal function (eGFR\<45 ml/min).
- Moderate to severe impairment of liver function (Child-Pugh class B or C).
- Severely impaired left ventricular ejection fraction (LVEF \<35%).
- Patients undergoing primary percutaneous coronary intervention (i.e., patients presenting with ST elevation myocardial infarction).
- Severe to very severe chronic obstructive pulmonary disease (GOLD class 3 to 4).
- Patients scheduled for cardiac surgery in the following 5 days.
- Inability to provide informed consent.
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04766008
Start Date
January 15 2020
End Date
April 30 2022
Last Update
April 12 2022
Active Locations (1)
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1
Humanitas Research Hospital
Rozzano, Milan, Italy, 20089