Short Term Outcomes After Primary PCI in Diabetic Patients Treated With Insulin Versus Oral Anti-diabetic Drugs

NCT06992466 | Not Yet Recruiting

• 1 other identifier: Diabetic patients after PPCI
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

• This study aims to compare the short-term clinical and echocardiographic outcomes of primary PCI in diabetic patients treated with insulin versus OADs.

Conditions

Diabetes Mellitus; PCI

Outcome Measures

Primary Outcomes (1)

• Short Term Outcomes after Primary PCI in Diabetic Patients Treated with Insulin Versus Oral Anti-diabetic Drugs

  To compare major adverse cardiovascular events (MACE) in insulin-treated versus OAD-treated diabetic patients undergoing primary PCI.

  baseline

Secondary Outcomes (1)

• Echocardiography

  baseline

Study Arms (1)

oral diabetic drugs

insulin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include 210 patients fulfilling our criteria presenting to emergency room of Assiut University hospitals. Patients will be involved in the study after obtaining a written informed consent and after approval of the faculty of medicine ethics committee.

You may qualify if:

• Patients with DM (type 2) undergoing primary PCI for STEMI.1-
• Treated with either insulin or OADs prior to admission.2-
• Age ≥18 year

You may not qualify if:

• Type 1 DM.1- Patients on both insulin and OADs.2- 3-Prior coronary artery bypass graft (CABG) surgery. 4-Severe renal impairment (eGFR \<30 mL/min/1.73m²). 5-Hemodynamically unstable patients 6-moderate to severe VHD 7-Patients who were shifted from OADs to insulin during Follow-up

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit

Asyut, Egypt

Location

Related Publications (3)

• Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.

  PMID: 30415602 BACKGROUND

• Abizaid A, Kornowski R, Mintz GS, Hong MK, Abizaid AS, Mehran R, Pichard AD, Kent KM, Satler LF, Wu H, Popma JJ, Leon MB. The influence of diabetes mellitus on acute and late clinical outcomes following coronary stent implantation. J Am Coll Cardiol. 1998 Sep;32(3):584-9. doi: 10.1016/s0735-1097(98)00286-1.

  PMID: 9741497 BACKGROUND

• Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998 Jul 23;339(4):229-34. doi: 10.1056/NEJM199807233390404.

  PMID: 9673301 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• ahmed

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ahmed

CONTACT

+201158931616; waleed.15235858@med.aun.edu.eg

Helmy

CONTACT

dr.hatemabdelrahman@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 28, 2025
• Study Start: May 20, 2025
• Primary Completion: January 25, 2026
• Study Completion: February 25, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

EG (1)