Trials / Unknown
UnknownNCT04766008
Metformin in Diabetic Patients Undergoing Coronary Angiography
Metformin Continuation Safety in Diabetic Patients Undergoing Coronary Angiography
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Humanitas Hospital, Italy · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 have taken metformin immediately before angiography and withhold metformin if renal function deteriorates. The aim of this study is to assess the safety of metformin in diabetic patients undergoing coronary angiography in terms of risk of lactic acidosis and to individuate eventual predictors of augmented lactate after coronary angiography.
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 historical cohort of diabetic patients taking metformin, we observed a mean value of lactate of 1.2+0.7 mmol/l. A total of 150 patients will be enrolled. Patients with any deviations from the study protocol will be enrolled in a parallel observational registry. The study consists of a screening phase, a 30-day observational phase, and an end-of-follow-up visit or phone interview. The total duration of participation in the study for each participant is approximately 30 days.
Conditions
- Diabetes Mellitus
- Coronary Artery Disease
- Lactic Acidosis With Diabetes Mellitus
- Contrast-induced Nephropathy
- Metformin Associated Lactic Acidosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metformin | Diabetic patients treated with metformin undergoing coronary angiography will not suspend metformin before and after PCI. |
Timeline
- Start date
- 2020-01-15
- Primary completion
- 2022-04-11
- Completion
- 2022-04-30
- First posted
- 2021-02-23
- Last updated
- 2022-04-12
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04766008. Inclusion in this directory is not an endorsement.