NO-STOP: Metformin in Diabetic Patients Undergoing Coronary Angiography

Sponsor
Humanitas Hospital, Italy (Other)
Overall Status
Recruiting
CT.gov ID
NCT04766008
Collaborator
(none)
150
1
1
27.5
5.5

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.

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

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Metformin Continuation Safety in Diabetic Patients Undergoing Coronary Angiography
Actual Study Start Date :
Jan 15, 2020
Actual Primary Completion Date :
Apr 11, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metformin continuation

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  1. Death [Within 30 days after the index coronary angiography]

    All cause mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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

Responsible Party:
Giulio Stefanini, Professor, Humanitas Hospital, Italy
ClinicalTrials.gov Identifier:
NCT04766008
Other Study ID Numbers:
  • 20190918
First Posted:
Feb 23, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Giulio Stefanini, Professor, Humanitas Hospital, Italy
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022