NO-STOP: Metformin in Diabetic Patients Undergoing Coronary Angiography
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Metformin continuation
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Drug: Metformin
Diabetic patients treated with metformin undergoing coronary angiography will not suspend metformin before and after PCI.
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Outcome Measures
Primary Outcome Measures
- Increase in lactate of 20% [From preprocedural values (same day of the coronary angiography) to 72 hours after coronary angiography]
Lactate will be measured from a venous sampling at three different time points, before coronary angiography, the day after (not mandatory) and 3 days after coronary angiography
Secondary Outcome Measures
- Contrast-associated acute kidney injury after coronary angiography. [From 0 to 7 days after coronary angiography]
Contrast-associated acute kidney injury was defined according to the KDIGO definition: increase in serum creatinine of 0.3 mg/dl within 48 hours from coronary angiography or >50% within 7 days (if creatinine after 7 days is available) or urine output of <0.5 ml/kg/hour for at least 6 hours
- Metformin associated lactic acidosis [At 24 and 72 hours after coronary angiography]
Lactic acidosis was defined as pH less than or equal to 7.35 and lactatemia greater than 2.2 mmol/L
Other Outcome Measures
- Death [Within 30 days after the index coronary angiography]
All cause mortality
Eligibility Criteria
Criteria
Inclusion Criteria:
- Diabetic patients treated with metformin undergoing coronary angiography.
Exclusion Criteria:
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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).
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Moderate to severe impairment of renal function (eGFR<45 ml/min).
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Moderate to severe impairment of liver function (Child-Pugh class B or C).
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Severely impaired left ventricular ejection fraction (LVEF <35%).
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Patients undergoing primary percutaneous coronary intervention (i.e., patients presenting with ST elevation myocardial infarction).
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Severe to very severe chronic obstructive pulmonary disease (GOLD class 3 to 4).
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Patients scheduled for cardiac surgery in the following 5 days.
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Inability to provide informed consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Humanitas Research Hospital | Rozzano | Milan | Italy | 20089 |
Sponsors and Collaborators
- Humanitas Hospital, Italy
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. Review.
- 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. Epub 2007 Jul 30.
- Maznyczka A, Myat A, Gershlick A. Discontinuation of metformin in the setting of coronary angiography: clinical uncertainty amongst physicians reflecting a poor evidence base. EuroIntervention. 2012 Jan;7(9):1103-10. doi: 10.4244/EIJV7I9A175. Review.
- Mehran R, Dangas GD, Weisbord SD. Contrast-Associated Acute Kidney Injury. Reply. N Engl J Med. 2019 Sep 26;381(13):1296-1297. doi: 10.1056/NEJMc1908879.
- 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.
- Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferović 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.
- Parra D, Legreid AM, Beckey NP, Reyes S. Metformin monitoring and change in serum creatinine levels in patients undergoing radiologic procedures involving administration of intravenous contrast media. Pharmacotherapy. 2004 Aug;24(8):987-93. Erratum in: Pharmacotherapy. 2004 Oct;24(10):1489.
- Pfisterer ME, Zellweger MJ. Therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009 Oct 1;361(14):1407; author reply 1409-10. doi: 10.1056/NEJMc091419.
- Timmer JR, Ottervanger JP, de Boer MJ, Dambrink JH, Hoorntje JC, Gosselink AT, Suryapranata H, Zijlstra F, van 't Hof AW; Zwolle Myocardial Infarction Study Group. Hyperglycemia is an important predictor of impaired coronary flow before reperfusion therapy in ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2005 Apr 5;45(7):999-1002.
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