Diabetes MellitusObservNCT06992466
Short Term Outcomes After Primary PCI in Diabetic Patients Treated With Insulin Versus Oral Anti-diabetic Drugs
An observational study of Diabetes Mellitus and PCI, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to compare the short-term clinical and echocardiographic outcomes of primary PCI in diabetic patients treated with insulin versus OADs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, PCI
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2025to 25 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with DM (type 2) undergoing primary PCI for STEMI.1-
- Treated with either insulin or OADs prior to admission.2-
- 3- Age ≥18 year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Helmy contact
About this study
- This study aims to compare the short-term clinical and echocardiographic outcomes of primary PCI in diabetic patients treated with insulin versus OADs.
Read the detailed description
- Diabetes mellitus (DM) is a major risk factor for cardiovascular disease (CVD), significantly increasing the risk of myocardial infarction (MI), heart failure, and mortality. Among patients with ST-segment elevation myocardial infarction (STEMI), diabetes is associated with higher rates of multi vessel disease, impaired coronary microcirculation, and poorer outcomes following percutaneous coronary intervention (PCI) compared to non-diabetic patients (1.2.3.4)
- Diabetes is an independent risk factor for the development of CAD. Coronary arteries in diabetic patients present extensive and diffuse atherosclerosis, longer and more complex lesions than in non-diabetic patients [5]. The relative risk of myocardial infarction (MI) is 50% higher in diabetic men and 150% higher in diabetic women [6]. Patients with type 2 DM have similar risk for cardiac events as subjects with a prior MI [7]. The risk of recurrence of MI in diabetic patients is more than 40% [8]. Due to high prevalence of acute MI in diabetic patients, adults with diabetes will lose 30 quality-adjusted life years compared to those without DM [9].
- Primary PCI is the gold-standard treatment for STEMI, offering superior outcomes compared to fibrinolysis. However, diabetic patients exhibit higher rates of in-stent restenosis, stent thrombosis, and recurrent ischemic events, making optimal glycemic control and choice of anti-diabetic therapy critical in improving post-PCI outcomes (10)
- Cardiac remodeling refers to a spectrum of structural and functional changes that occur in the heart in response to myocardial injury or increased hemodynamic load, such as after myocardial infarction, chronic hypertension, or valvular heart disease. These changes may include alterations in ventricular size, shape, wall thickness, and overall function, and they are strongly associated with adverse cardiovascular outcomes including heart failure and sudden cardiac death. Echocardiography is a cornerstone non-invasive imaging modality that plays a vital role in the assessment and monitoring of cardiac remodeling. It offers real-time evaluation of cardiac chamber dimensions, wall thickness, ventricular volumes, ejection fraction, myocardial deformation (strain), and diastolic function. These echocardiographic parameters not only reflect the extent of remodeling but also have prognostic significance in various cardiac conditions.(11)
- Impact of Diabetes Treatment on Cardiovascular Outcomes
The choice of anti-diabetic therapy may influence cardiovascular outcomes in STEMI patients undergoing PCI. There are two main therapeutic strategies for diabetes management:
Insulin therapy: Often used in patients with long-standing or poorly controlled diabetes, but is associated with increased risks of hypoglycemia, weight gain, and potential pro-inflammatory effects, which may contribute to worse cardiovascular outcomes (12.13)
Oral anti-diabetic drugs (OADs): Certain newer agents, such as SGLT2 inhibitors and GLP-1 receptor agonists, have demonstrated cardio protective effects, while others like sulfonylureas may be associated with an increased risk of adverse cardiovascular events (14)
Despite these differences, data on the impact of insulin versus OADs on PCI outcomes remain inconclusive, necessitating further research
- Conditions
- Diabetes Mellitus, PCI
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| oral diabetic drugs | insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (1)
Echocardiography
Echocardiographic assessment of cardiac Remodeling early and 3 months post primary PCI
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start20 May 2025 (estimated)
- Primary completion25 Jan 2026 (estimated)
- Study completion25 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid shehata ahmed, Assiut University
- Investigators
- ahmed, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992466
- Sponsor's protocol ID
- Diabetic patients after PPCI
- Acronym
- Observ
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30415602Abizaid 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.
PubMed 9741497Haffner 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.
PubMed 9673301
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcomes After Primary PCI in Diabetic Patients Treated With Insulin Versus Oral Anti-diabetic Drugs
- ClinicalTrials.gov ID
- NCT06992466
- Acronym / sponsor ID
- Observ / Diabetic patients after PPCI
- Conditions
- Diabetes Mellitus, PCI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 25 Jan 2026 (estimated)
- Study completion
- 25 Feb 2026 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- This study aims to compare the short-term clinical and echocardiographic outcomes of primary PCI in diabetic patients treated with insulin versus OADs.
Detailed description
- Diabetes mellitus (DM) is a major risk factor for cardiovascular disease (CVD), significantly increasing the risk of myocardial infarction (MI), heart failure, and mortality. Among patients with ST-segment elevation myocardial infarction (STEMI), diabetes is associated with higher rates of multi vessel disease, impaired coronary microcirculation, and poorer outcomes following percutaneous coronary intervention (PCI) compared to non-diabetic patients (1.2.3.4)
- Diabetes is an independent risk factor for the development of CAD. Coronary arteries in diabetic patients present extensive and diffuse atherosclerosis, longer and more complex lesions than in non-diabetic patients [5]. The relative risk of myocardial infarction (MI) is 50% higher in diabetic men and 150% higher in diabetic women [6]. Patients with type 2 DM have similar risk for cardiac events as subjects with a prior MI [7]. The risk of recurrence of MI in diabetic patients is more than 40% [8]. Due to high prevalence of acute MI in diabetic patients, adults with diabetes will lose 30 quality-adjusted life years compared to those without DM [9].
- Primary PCI is the gold-standard treatment for STEMI, offering superior outcomes compared to fibrinolysis. However, diabetic patients exhibit higher rates of in-stent restenosis, stent thrombosis, and recurrent ischemic events, making optimal glycemic control and choice of anti-diabetic therapy critical in improving post-PCI outcomes (10)
- Cardiac remodeling refers to a spectrum of structural and functional changes that occur in the heart in response to myocardial injury or increased hemodynamic load, such as after myocardial infarction, chronic hypertension, or valvular heart disease. These changes may include alterations in ventricular size, shape, wall thickness, and overall function, and they are strongly associated with adverse cardiovascular outcomes including heart failure and sudden cardiac death. Echocardiography is a cornerstone non-invasive imaging modality that plays a vital role in the assessment and monitoring of cardiac remodeling. It offers real-time evaluation of cardiac chamber dimensions, wall thickness, ventricular volumes, ejection fraction, myocardial deformation (strain), and diastolic function. These echocardiographic parameters not only reflect the extent of remodeling but also have prognostic significance in various cardiac conditions.(11)
- Impact of Diabetes Treatment on Cardiovascular Outcomes
The choice of anti-diabetic therapy may influence cardiovascular outcomes in STEMI patients undergoing PCI. There are two main therapeutic strategies for diabetes management:
Insulin therapy: Often used in patients with long-standing or poorly controlled diabetes, but is associated with increased risks of hypoglycemia, weight gain, and potential pro-inflammatory effects, which may contribute to worse cardiovascular outcomes (12.13)
Oral anti-diabetic drugs (OADs): Certain newer agents, such as SGLT2 inhibitors and GLP-1 receptor agonists, have demonstrated cardio protective effects, while others like sulfonylureas may be associated with an increased risk of adverse cardiovascular events (14)
Despite these differences, data on the impact of insulin versus OADs on PCI outcomes remain inconclusive, necessitating further research
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral diabetic drugs | – | –insulin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with DM (type 2) undergoing primary PCI for STEMI.1-
- Treated with either insulin or OADs prior to admission.2-
- 3- Age ≥18 year
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short Term Outcomes after Primary PCI in Diabetic Patients Treated with Insulin Versus Oral Anti-diabetic Drugs
Time frame: baseline
To compare major adverse cardiovascular events (MACE) in insulin-treated versus OAD-treated diabetic patients undergoing primary PCI.
1 secondary outcome
Echocardiography
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 30415602Wiviott 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.
- Background: PubMed 9741497Abizaid 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.
- Background: PubMed 9673301Haffner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helmy contact
ahmed study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and PCI, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed (+201158931616, waleed.15235858@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Term Outcomes after Primary PCI in Diabetic Patients Treated with Insulin Versus Oral Anti-diabetic Drugs (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06992466, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.