Metformin in Diabetic Patients Undergoing Coronary Angiography

NCT04766008 | Unknown Phase 4 DMC

• 1 other identifier: 20190918
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Increase in lactate of 20%

  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

  From preprocedural values (same day of the coronary angiography) to 72 hours after coronary angiography

Secondary Outcomes (2)

• Contrast-associated acute kidney injury after coronary angiography.

  From 0 to 7 days after coronary angiography

• Metformin associated lactic acidosis

  At 24 and 72 hours after coronary angiography

Other Outcomes (1)

• Death

  Within 30 days after the index coronary angiography

Study Arms (1)

Metformin continuation

EXPERIMENTAL

Drug: Metformin

Interventions

Metformin DRUG

Diabetic patients treated with metformin undergoing coronary angiography will not suspend metformin before and after PCI.

Metformin continuation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients treated with metformin undergoing coronary angiography.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Humanitas Hospital, Italy: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

Related Publications (10)

• 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. No abstract available.

  PMID: 19797290 BACKGROUND

• Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. doi: 10.1056/NEJM199602293340906. No abstract available.

  PMID: 8569826 BACKGROUND

• 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.

  PMID: 21959259 BACKGROUND

• 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. doi: 10.1016/j.jacc.2004.12.050.

  PMID: 15808754 BACKGROUND

• 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. No abstract available.

  PMID: 31553855 BACKGROUND

• 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.

  PMID: 30667361 BACKGROUND

• 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. doi: 10.1592/phco.24.11.987.36131.

  PMID: 15338847 BACKGROUND

• 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.

  PMID: 9630271 BACKGROUND

• 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.

  PMID: 17692741 BACKGROUND

• Chiarito M, Sanz-Sanchez J, Piccolo R, Condello F, Liccardo G, Maurina M, Avvedimento M, Regazzoli D, Pagnotta P, Garcia-Garcia HM, Mehran R, Federici M, Condorelli G, Diez Gil JL, Reimers B, Ferrante G, Stefanini G. Safety of metformin continuation in diabetic patients undergoing invasive coronary angiography: the NO-STOP single arm trial. Cardiovasc Diabetol. 2023 Feb 6;22(1):28. doi: 10.1186/s12933-023-01744-4.

  PMID: 36747244 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Coronary Artery Disease; Acidosis, Lactic

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Acidosis; Acid-Base Imbalance

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Giulio Stefanini, MD, PhD

CONTACT

+390282247384; giulio.stefanini@gmail.com

Mauro Chiarito, MD

CONTACT

+390282247009; mauro.chiarito@humanitas.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 23, 2021
• Study Start: January 15, 2020
• Primary Completion: April 11, 2022
• Study Completion: April 30, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

IT (1)