Clinical trial NCT04766008: Metformin in Diabetic Patients Undergoing Coronary Angiography
Official title: Metformin Continuation Safety in Diabetic Patients Undergoing Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Coronary Artery Disease
Lactic Acidosis With Diabetes Mellitus
Contrast-induced Nephropathy
Metformin Associated Lactic Acidosis
Keywords: metformin
coronary angiography
diabetes mellitus
lactic acidosis
Lead sponsor: Humanitas Hospital, Italy
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

* Diabetic patients treated with metformin undergoing coronary angiography.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Increase in lactate of 20%
timeFrame: From preprocedural values (same day of the coronary angiography) to 72 hours after coronary angiography
Secondary outcomes:
measure: Contrast-associated acute kidney injury after coronary angiography.
timeFrame: From 0 to 7 days after coronary angiography
measure: Metformin associated lactic acidosis
timeFrame: At 24 and 72 hours after coronary angiography
Other outcomes:
measure: Death
timeFrame: Within 30 days after the index coronary angiography
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
References:
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citation: Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO. 2018 ESC/EACTS Guidelines on myocardial revascularization. EuroIntervention. 2019 Feb 20;14(14):1435-1534. doi: 10.4244/EIJY19M01_01. No abstract available.
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citation: Nawaz S, Cleveland T, Gaines PA, Chan P. Clinical risk associated with contrast angiography in metformin treated patients: a clinical review. Clin Radiol. 1998 May;53(5):342-4. doi: 10.1016/s0009-9260(98)80005-6.
citation: Laskey WK, Jenkins C, Selzer F, Marroquin OC, Wilensky RL, Glaser R, Cohen HA, Holmes DR Jr; NHLBI Dynamic Registry Investigators. Volume-to-creatinine clearance ratio: a pharmacokinetically based risk factor for prediction of early creatinine increase after percutaneous coronary intervention. J Am Coll Cardiol. 2007 Aug 14;50(7):584-90. doi: 10.1016/j.jacc.2007.03.058. Epub 2007 Jul 30.