NCT05261867

Brief Summary

Despite their potential benefits on the heart with pleiotropic mechanisms, the cardioprotective effects of new glucose-lowering SGLT-2 inhibitors in patients with myocardial infarction - both in the acute and chronic phase - have never been explored. The key point of the project will be the evaluation of the cardioprotective effect and the potential prognostic benefit of SGLT-2 inhibitors in patients with diabetes and acute myocardial infarction.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
3 countries

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

4.8 years

First QC Date

February 10, 2022

Last Update Submit

October 20, 2022

Conditions

Diabetes MellitusAcute Coronary Syndrome

Keywords

SGLT2-IAcute myocardial infarctionDiabetes MellitusPrognosis

Outcome Measures

Primary Outcomes (1)

  • Composite of cardiovascular death, recurrent AMI, and hospitalization for HF (MACE).

    Composite of cardiovascular death, recurrent AMI, and hospitalization for HF (MACE).

    Through study completion, an average of 2 year

Secondary Outcomes (11)

  • Intra-hospital cardiovascular death

    Up to 30 days

  • Intra-hospital atrial and ventricular arrhythmias

    Up to 30 days

  • Reduction of the infarct size

    Up to 30 days

  • Reduction of the inflammatory response.

    Up to 30 days

  • Contrast-induced acute kidney injury

    Through study completion, an average of 1 year

  • +6 more secondary outcomes

Study Arms (2)

Diabetic patients treated with SGLT2-I

Diabetic patients treated with SGLT2-I alone or in combination with other oral anti-diabetic (OAD) agents. Patients were considered in the SGLT2-I group if it was started at least 1 month prior to index hospitalization.

Diabetic patients treated with other oral anti-diabetic (OAD) agents

Diabetic patients treated with other oral anti-diabetic agents alone.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with STEMI/NSTEMI diagnosed according to ESC guidelines undergoing reperfusion treatment with percutaneous transluminal coronary angioplasty (PTCA) with known type II diabetes mellitus treated with oral antidiabetic drugs.

You may qualify if:

  • Age ≥18 y old
  • STEMI/NSTEMI diagnosed according to ESC guidelines undergoing reperfusion treatment with percutaneous transluminal coronary angioplasty (PTCA).
  • Known type II diabetes mellitus treated with oral antidiabetic drugs

You may not qualify if:

  • Type I diabetes mellitus or type II diabetes mellitus treated only with insulin therapy alone or in combination with other anti-diabetic drugs.
  • Patients treated with Coronary artery bypass grafting (CABG) after the coronary angiography (CAG) (NSTEMI)
  • Previous CABG
  • Severe valvular heart disease.
  • Contraindications for secondary medical prevention therapy approved for myocardial infarctions, like beta-blockers, angiotensin-converting enzyme inhibitor(ACEI )/angiotensin receptor blocker (ARBs), antiplatelets, statins. All patients will be treated with optimal secondary prevention therapy suggested by the current ESC guidelines.
  • Patients who start SGLT2 therapy after the acute index event.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium

Aalst, 9300, Belgium

RECRUITING

Alexandrovska University Hospital, Sofia, Bulgaria

Sofia, Bulgaria

RECRUITING

Policlinico Sant'Orsola

Bologna, Italy

RECRUITING

Azienda Ospedaliera Sant'Anna e San Sebastiano, Caserta

Caserta, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda, Milano

Milan, Italy

RECRUITING

Università Vanvitelli, Ospedale Cardarelli, Napoli

Napoli, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea, Roma

Roma, Italy

RECRUITING

Related Publications (10)

  • Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.

    PMID: 30571511RESULT

  • Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.

    PMID: 23281415RESULT

  • Andreadou I, Bell RM, Botker HE, Zuurbier CJ. SGLT2 inhibitors reduce infarct size in reperfused ischemic heart and improve cardiac function during ischemic episodes in preclinical models. Biochim Biophys Acta Mol Basis Dis. 2020 Jul 1;1866(7):165770. doi: 10.1016/j.bbadis.2020.165770. Epub 2020 Mar 17.

    PMID: 32194159RESULT

  • Tanajak P, Sa-Nguanmoo P, Sivasinprasasn S, Thummasorn S, Siri-Angkul N, Chattipakorn SC, Chattipakorn N. Cardioprotection of dapagliflozin and vildagliptin in rats with cardiac ischemia-reperfusion injury. J Endocrinol. 2018 Feb;236(2):69-84. doi: 10.1530/JOE-17-0457. Epub 2017 Nov 15.

    PMID: 29142025RESULT

  • Lahnwong C, Palee S, Apaijai N, Sriwichaiin S, Kerdphoo S, Jaiwongkam T, Chattipakorn SC, Chattipakorn N. Acute dapagliflozin administration exerts cardioprotective effects in rats with cardiac ischemia/reperfusion injury. Cardiovasc Diabetol. 2020 Jun 15;19(1):91. doi: 10.1186/s12933-020-01066-9.

    PMID: 32539724RESULT

  • Lee TM, Chang NC, Lin SZ. Dapagliflozin, a selective SGLT2 Inhibitor, attenuated cardiac fibrosis by regulating the macrophage polarization via STAT3 signaling in infarcted rat hearts. Free Radic Biol Med. 2017 Mar;104:298-310. doi: 10.1016/j.freeradbiomed.2017.01.035. Epub 2017 Jan 26.

    PMID: 28132924RESULT

  • Sayour AA, Celeng C, Olah A, Ruppert M, Merkely B, Radovits T. Sodium-glucose cotransporter 2 inhibitors reduce myocardial infarct size in preclinical animal models of myocardial ischaemia-reperfusion injury: a meta-analysis. Diabetologia. 2021 Apr;64(4):737-748. doi: 10.1007/s00125-020-05359-2. Epub 2021 Jan 23.

    PMID: 33483761RESULT

  • Paolisso P, Bergamaschi L, Gragnano F, Gallinoro E, Cesaro A, Sardu C, Mileva N, Foa A, Armillotta M, Sansonetti A, Amicone S, Impellizzeri A, Esposito G, Morici N, Andrea OJ, Casella G, Mauro C, Vassilev D, Galie N, Santulli G, Marfella R, Calabro P, Pizzi C, Barbato E. Outcomes in diabetic patients treated with SGLT2-Inhibitors with acute myocardial infarction undergoing PCI: The SGLT2-I AMI PROTECT Registry. Pharmacol Res. 2023 Jan;187:106597. doi: 10.1016/j.phrs.2022.106597. Epub 2022 Dec 5.

    PMID: 36470546DERIVED

  • Cesaro A, Gragnano F, Paolisso P, Bergamaschi L, Gallinoro E, Sardu C, Mileva N, Foa A, Armillotta M, Sansonetti A, Amicone S, Impellizzeri A, Esposito G, Morici N, Oreglia JA, Casella G, Mauro C, Vassilev D, Galie N, Santulli G, Pizzi C, Barbato E, Calabro P, Marfella R. In-hospital arrhythmic burden reduction in diabetic patients with acute myocardial infarction treated with SGLT2-inhibitors: Insights from the SGLT2-I AMI PROTECT study. Front Cardiovasc Med. 2022 Sep 27;9:1012220. doi: 10.3389/fcvm.2022.1012220. eCollection 2022.

    PMID: 36237914DERIVED

  • Paolisso P, Bergamaschi L, Santulli G, Gallinoro E, Cesaro A, Gragnano F, Sardu C, Mileva N, Foa A, Armillotta M, Sansonetti A, Amicone S, Impellizzeri A, Casella G, Mauro C, Vassilev D, Marfella R, Calabro P, Barbato E, Pizzi C. Infarct size, inflammatory burden, and admission hyperglycemia in diabetic patients with acute myocardial infarction treated with SGLT2-inhibitors: a multicenter international registry. Cardiovasc Diabetol. 2022 May 15;21(1):77. doi: 10.1186/s12933-022-01506-8.

    PMID: 35570280DERIVED

MeSH Terms

Conditions

Diabetes MellitusAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Carmine Pizzi, MD

CONTACT

carmine.pizzi@unibo.it

Pizzi Carmine, MD

CONTACT

carmine.pizzi@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

March 2, 2022

Study Start

January 1, 2017

Primary Completion

November 1, 2021

Study Completion

January 1, 2023

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(5)BE(1)BU(1)