STEMINCT07706335
Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.
An observational study of STEMI and No-Reflow Phenomenon, run by Assiut University.
Trial summary
To investigate the relationship between the TyG index, coronary lesion complexity assessed by the SYNTAX score, and the development of the no-reflow phenomenon in STEMI patients with T2DM. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- STEMI, No-Reflow Phenomenon, Diabetic Patient
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Aug 2029
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clinical, Laboratory, Insulin Resistance, and Angiographic Assessment Eligible patients with type 2 diabetes mellitus presenting with STEMI and undergoing primary PCI were prospectively evaluated. Clinical data included age, sex, BMI, cardiovascular risk factors, diabetes duration, ischemic time, Killip class, and infarct location. Laboratory investigations included fasting plasma glucose, HbA1c, lipid profile, CBC, serum creatinine, cardiac biomarkers, and hs-CRP. Insulin resistance was assessed using the triglyceride-glucose (TyG) index: ln [fasting triglycerides × fasting plasma glucose ÷ 2]. Coronary angiography assessed the infarct-related artery, TIMI flow, thrombus grade, lesion characteristics, and SYNTAX score. The primary endpoint was the occurrence of the no-reflow phenomenon after primary PCI.
Who may be able to join
- Age ≥ 18 years
- Type 2 Diabetes Mellitus patients .
- Undergoing PCI for STEMI.
- Written informed consent obtained.
Who cannot join
- 1. Individuals with a previous history of myocardial infarction (MI) or decompensated heart failure.
- 2. Individuals with Cardiogenic shock. 3. Individuals with a history of PCI or coronary artery bypass grafting (CABG). 4.Previous familial mixed dyslipidemia / Hypertriglycerideemia (Homozygous or heterozygous).
- 5.Patients with significant hepatic impairment (transaminase levels ≥ 2x normal value).
- 6.Patients with renal impairment (GFR < 60 mL/min/1.73 m²). 7.Active infection or inflammatory disease. 8.Known autoimmune disease. 9.Malignancy. 10. Type 1 Diabetes Mellitus patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To investigate the relationship between the TyG index, coronary lesion complexity assessed by the SYNTAX score, and the development of the no-reflow phenomenon in STEMI patients with T2DM.
Read the detailed description
Successful restoration of epicardial coronary artery patency in acute myocardial infarction (AMI) does not always guarantee adequate myocardial tissue perfusion or effective salvage of ischemic myocardium. In a substantial proportion of patients, microvascular dysfunction persists despite successful recanalization after percutaneous coronary intervention (PCI), limiting the expected clinical benefit of reperfusion therapy. This condition, known as the no-reflow phenomenon, is characterized by inadequate myocardial perfusion in the absence of angiographic evidence of mechanical vessel obstruction. No-reflow occurs in 2-60% of patients with ST-segment elevation myocardial infarction (STEMI) and is strongly associated with adverse ventricular remodeling, malignant arrhythmias, heart failure, and increased short- and long-term mortality.
Distal embolization of thrombus and plaque debris during PCI is a major mechanism underlying microvascular obstruction and no-reflow, emphasizing the importance of identifying high-risk coronary lesions before intervention. The SYNTAX score, an angiographic tool reflecting coronary lesion complexity, has been shown to predict clinical outcomes and the occurrence of no-reflow in patients undergoing PCI. Patients with type 2 diabetes mellitus (T2DM) represent a particularly vulnerable group, as they frequently exhibit more complex coronary lesions and a higher incidence of no-reflow.
Insulin resistance (IR) plays a central role in endothelial dysfunction, vascular inflammation, and atherothrombosis. The triglyceride-glucose (TyG) index, a simple and reliable surrogate of IR, has been associated with adverse cardiovascular outcomes and has recently been shown to predict the occurrence of no-reflow in STEMI patients with T2DM undergoing PCI.
- Conditions
- STEMI, No-Reflow Phenomenon, Diabetic Patient
- Being tested
- PCI
- Medical subject headings
- ST Elevation Myocardial Infarction, No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
All eligible patients presenting with ST-segment elevation myocardial infarction (STEMI) will undergo primary percutaneous coronary intervention (PPCI)
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic patient | Inclusion criteria:
1. Age ≥ 18 years 2.Type 2 Diabetes Mellitus patients . 3.Undergoing PCI for STEMI. 4.Written informed consent obtained. 2.4.5-Exclusion criteria :
1. Individuals with a previous history of myocardial infarction (MI) or decompensated heart failure.
2. Individuals with Cardiogenic shock.
3. Individuals with a history of PCI or coronary artery bypass grafting (CABG).
4. Previous familial mixed dyslipidemia / Hypertriglycerideemia (Homozygous or heterozygous).
5. Patients with significant hepatic impairment (transaminase levels ≥ 2x normal value).
6. Patients with renal impairment (GFR < 60 mL/min/1.73 m²).
7. Active infection or inflammatory disease.
8. Known autoimmune disease.
9. Malignancy.
10. Type 1 Diabetes Mellitus patients. Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
SYNTAX Score (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery Score)
Assessment of the association between the triglyceride-glucose (TyG) index and the SYNTAX score in patients with type 2 diabetes mellitus undergoing primary PCI for STEMI.
Scale details:
Minimum value: 0 Maximum value: No fixed maximum (the score is unbounded and increases according to the number, complexity, and location of coronary lesions).
Interpretation: Higher SYNTAX scores indicate greater coronary artery disease complexity and worse angiographic severity.
Measured: through study completion, an average of 2 year
No reflow phenomenon
- To evaluate the relationship between TyG index and the occurrence of the no-reflow phenomenon after PCI.
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
MACEs
- To assess the relationship between insulin resistance markers and in-hospital major adverse cardiac events (MACEs).
Measured: through study completion, an average of 2 year
Area under the receiver operating characteristic (ROC) curve of the triglyceride-glucose (TyG) index for predicting the no-reflow phenomenon
The discriminatory performance of the TyG index for predicting the occurrence of the no-reflow phenomenon after primary PCI will be assessed by the area under the ROC curve (AUC), with the optimal cutoff value, sensitivity, specificity, positive predictive value, and negative predictive value reported.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed Abd-Elhmied Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706335
- Sponsor's protocol ID
- noreflow in STEMI
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ndrepepa G, Tiroch K, Fusaro M, Keta D, Seyfarth M, Byrne RA, Pache J, Alger P, Mehilli J, Schomig A, Kastrati A. 5-year prognostic value of no-reflow phenomenon after percutaneous coronary intervention in patients with acute myocardial infarction. J Am Coll Cardiol. 2010 May 25;55(21):2383-9. doi: 10.1016/j.jacc.2009.12.054.
PubMed 20488311Pathak R, Hauer-Jensen M. Particle Beam may have Higher Effectiveness in Treating Chemo-resistant Cancers than Low-LET Photon Beam Therapy. Res Rev J Pharm Pharm Sci. 2015 Apr-Jun;4(2):1-2. Epub 2015 Jun 14. No abstract available.
PubMed 26779544Xie X, Tang B, Zhou J, Gao Q, Zhang P. Inhibition of the PI3K/Akt pathway increases the chemosensitivity of gastric cancer to vincristine. Oncol Rep. 2013 Aug;30(2):773-82. doi: 10.3892/or.2013.2520. Epub 2013 Jun 5.
PubMed 23743572Matza D, Badou A, Jha MK, Willinger T, Antov A, Sanjabi S, Kobayashi KS, Marchesi VT, Flavell RA. Requirement for AHNAK1-mediated calcium signaling during T lymphocyte cytolysis. Proc Natl Acad Sci U S A. 2009 Jun 16;106(24):9785-90. doi: 10.1073/pnas.0902844106. Epub 2009 Jun 2.
PubMed 19497879Kacerova S, Muchova M, Doudova H, Munster L, Hanulikova B, Valaskova K, Kasparkova V, Kuritka I, Humpolicek P, Vichova Z, Vasicek O, Vicha J. Chitosan/dialdehyde cellulose hydrogels with covalently anchored polypyrrole: Novel conductive, antibacterial, antioxidant, immunomodulatory, and anti-inflammatory materials. Carbohydr Polym. 2024 Mar 1;327:121640. doi: 10.1016/j.carbpol.2023.121640. Epub 2023 Nov 28.
PubMed 38171669Liu J, Teh WL, Tan RHS, Chang SSH, Lau BJ, Chandwani N, Tor PC, Subramaniam M. Evaluating a maladaptive personality-informed model of social support and post-traumatic stress disorder. J Affect Disord. 2024 Sep 15;361:209-216. doi: 10.1016/j.jad.2024.05.164. Epub 2024 May 29.
PubMed 38821368Calafate S, Ozturan G, Thrupp N, Vanderlinden J, Santa-Marinha L, Morais-Ribeiro R, Ruggiero A, Bozic I, Rusterholz T, Lorente-Echeverria B, Dias M, Chen WT, Fiers M, Lu A, Vlaeminck I, Creemers E, Craessaerts K, Vandenbempt J, van Boekholdt L, Poovathingal S, Davie K, Thal DR, Wierda K, Oliveira TG, Slutsky I, Adamantidis A, De Strooper B, de Wit J. Early alterations in the MCH system link aberrant neuronal activity and sleep disturbances in a mouse model of Alzheimer's disease. Nat Neurosci. 2023 Jun;26(6):1021-1031. doi: 10.1038/s41593-023-01325-4. Epub 2023 May 15.
PubMed 37188873
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.
- ClinicalTrials.gov ID
- NCT07706335
- Acronym / sponsor ID
- noreflow in STEMI
- Conditions
- STEMI, No-Reflow Phenomenon, Diabetic Patient
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 15 Jul 2026 (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.
To investigate the relationship between the TyG index, coronary lesion complexity assessed by the SYNTAX score, and the development of the no-reflow phenomenon in STEMI patients with T2DM.
Detailed description
Successful restoration of epicardial coronary artery patency in acute myocardial infarction (AMI) does not always guarantee adequate myocardial tissue perfusion or effective salvage of ischemic myocardium. In a substantial proportion of patients, microvascular dysfunction persists despite successful recanalization after percutaneous coronary intervention (PCI), limiting the expected clinical benefit of reperfusion therapy. This condition, known as the no-reflow phenomenon, is characterized by inadequate myocardial perfusion in the absence of angiographic evidence of mechanical vessel obstruction. No-reflow occurs in 2-60% of patients with ST-segment elevation myocardial infarction (STEMI) and is strongly associated with adverse ventricular remodeling, malignant arrhythmias, heart failure, and increased short- and long-term mortality.
Distal embolization of thrombus and plaque debris during PCI is a major mechanism underlying microvascular obstruction and no-reflow, emphasizing the importance of identifying high-risk coronary lesions before intervention. The SYNTAX score, an angiographic tool reflecting coronary lesion complexity, has been shown to predict clinical outcomes and the occurrence of no-reflow in patients undergoing PCI. Patients with type 2 diabetes mellitus (T2DM) represent a particularly vulnerable group, as they frequently exhibit more complex coronary lesions and a higher incidence of no-reflow.
Insulin resistance (IR) plays a central role in endothelial dysfunction, vascular inflammation, and atherothrombosis. The triglyceride-glucose (TyG) index, a simple and reliable surrogate of IR, has been associated with adverse cardiovascular outcomes and has recently been shown to predict the occurrence of no-reflow in STEMI patients with T2DM undergoing PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic patient | – | Procedure: PCIInclusion criteria: 1. Age ≥ 18 years 2.Type 2 Diabetes Mellitus patients . 3.Undergoing PCI for STEMI. 4.Written informed consent obtained. 2.4.5-Exclusion criteria : 1. Individuals with a previous history of myocardial infarction (MI) or decompensated heart failure. 2. Individuals with Cardiogenic shock. 3. Individuals with a history of PCI or coronary artery bypass grafting (CABG). 4. Previous familial mixed dyslipidemia / Hypertriglycerideemia (Homozygous or heterozygous). 5. Patients with significant hepatic impairment (transaminase levels ≥ 2x normal value). 6. Patients with renal impairment (GFR < 60 mL/min/1.73 m²). 7. Active infection or inflammatory disease. 8. Known autoimmune disease. 9. Malignancy. 10. Type 1 Diabetes Mellitus patients. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical, Laboratory, Insulin Resistance, and Angiographic Assessment Eligible patients with type 2 diabetes mellitus presenting with STEMI and undergoing primary PCI were prospectively evaluated. Clinical data included age, sex, BMI, cardiovascular risk factors, diabetes duration, ischemic time, Killip class, and infarct location. Laboratory investigations included fasting plasma glucose, HbA1c, lipid profile, CBC, serum creatinine, cardiac biomarkers, and hs-CRP. Insulin resistance was assessed using the triglyceride-glucose (TyG) index: ln [fasting triglycerides × fasting plasma glucose ÷ 2]. Coronary angiography assessed the infarct-related artery, TIMI flow, thrombus grade, lesion characteristics, and SYNTAX score. The primary endpoint was the occurrence of the no-reflow phenomenon after primary PCI.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Type 2 Diabetes Mellitus patients .
- Undergoing PCI for STEMI.
- Written informed consent obtained.
Key exclusion criteria (4 listed)
- 1. Individuals with a previous history of myocardial infarction (MI) or decompensated heart failure.
- 2. Individuals with Cardiogenic shock. 3. Individuals with a history of PCI or coronary artery bypass grafting (CABG). 4.Previous familial mixed dyslipidemia / Hypertriglycerideemia (Homozygous or heterozygous).
- 5.Patients with significant hepatic impairment (transaminase levels ≥ 2x normal value).
- 6.Patients with renal impairment (GFR < 60 mL/min/1.73 m²). 7.Active infection or inflammatory disease. 8.Known autoimmune disease. 9.Malignancy. 10. Type 1 Diabetes Mellitus patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCIAll eligible patients presenting with ST-segment elevation myocardial infarction (STEMI) will undergo primary percutaneous coronary intervention (PPCI) | Procedure or surgery | Type 2 diabetic patient |
Primary outcome
SYNTAX Score (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery Score)
Time frame: through study completion, an average of 2 year
Assessment of the association between the triglyceride-glucose (TyG) index and the SYNTAX score in patients with type 2 diabetes mellitus undergoing primary PCI for STEMI. Scale details: Minimum value: 0 Maximum value: No fixed maximum (the score is unbounded and increases according to the number, complexity, and location of coronary lesions). Interpretation: Higher SYNTAX scores indicate greater coronary artery disease complexity and worse angiographic severity.
No reflow phenomenon
Time frame: through study completion, an average of 2 year
2. To evaluate the relationship between TyG index and the occurrence of the no-reflow phenomenon after PCI.
2 secondary outcomes
MACEs
Time frame: through study completion, an average of 2 year
Area under the receiver operating characteristic (ROC) curve of the triglyceride-glucose (TyG) index for predicting the no-reflow phenomenon
Time frame: through study completion, an average of 2 year
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 16 Jul 2026.
- Background: PubMed 20488311Ndrepepa G, Tiroch K, Fusaro M, Keta D, Seyfarth M, Byrne RA, Pache J, Alger P, Mehilli J, Schomig A, Kastrati A. 5-year prognostic value of no-reflow phenomenon after percutaneous coronary intervention in patients with acute myocardial infarction. J Am Coll Cardiol. 2010 May 25;55(21):2383-9. doi: 10.1016/j.jacc.2009.12.054.
- Background: PubMed 26779544Pathak R, Hauer-Jensen M. Particle Beam may have Higher Effectiveness in Treating Chemo-resistant Cancers than Low-LET Photon Beam Therapy. Res Rev J Pharm Pharm Sci. 2015 Apr-Jun;4(2):1-2. Epub 2015 Jun 14. No abstract available.
- Background: PubMed 23743572Xie X, Tang B, Zhou J, Gao Q, Zhang P. Inhibition of the PI3K/Akt pathway increases the chemosensitivity of gastric cancer to vincristine. Oncol Rep. 2013 Aug;30(2):773-82. doi: 10.3892/or.2013.2520. Epub 2013 Jun 5.
- Background: PubMed 19497879Matza D, Badou A, Jha MK, Willinger T, Antov A, Sanjabi S, Kobayashi KS, Marchesi VT, Flavell RA. Requirement for AHNAK1-mediated calcium signaling during T lymphocyte cytolysis. Proc Natl Acad Sci U S A. 2009 Jun 16;106(24):9785-90. doi: 10.1073/pnas.0902844106. Epub 2009 Jun 2.
- Background: PubMed 38171669Kacerova S, Muchova M, Doudova H, Munster L, Hanulikova B, Valaskova K, Kasparkova V, Kuritka I, Humpolicek P, Vichova Z, Vasicek O, Vicha J. Chitosan/dialdehyde cellulose hydrogels with covalently anchored polypyrrole: Novel conductive, antibacterial, antioxidant, immunomodulatory, and anti-inflammatory materials. Carbohydr Polym. 2024 Mar 1;327:121640. doi: 10.1016/j.carbpol.2023.121640. Epub 2023 Nov 28.
- Background: PubMed 38821368Liu J, Teh WL, Tan RHS, Chang SSH, Lau BJ, Chandwani N, Tor PC, Subramaniam M. Evaluating a maladaptive personality-informed model of social support and post-traumatic stress disorder. J Affect Disord. 2024 Sep 15;361:209-216. doi: 10.1016/j.jad.2024.05.164. Epub 2024 May 29.
- Background: PubMed 37188873Calafate S, Ozturan G, Thrupp N, Vanderlinden J, Santa-Marinha L, Morais-Ribeiro R, Ruggiero A, Bozic I, Rusterholz T, Lorente-Echeverria B, Dias M, Chen WT, Fiers M, Lu A, Vlaeminck I, Creemers E, Craessaerts K, Vandenbempt J, van Boekholdt L, Poovathingal S, Davie K, Thal DR, Wierda K, Oliveira TG, Slutsky I, Adamantidis A, De Strooper B, de Wit J. Early alterations in the MCH system link aberrant neuronal activity and sleep disturbances in a mouse model of Alzheimer's disease. Nat Neurosci. 2023 Jun;26(6):1021-1031. doi: 10.1038/s41593-023-01325-4. Epub 2023 May 15.
- Mazhar J, Mashicharan M, Farshid A, et al. Predictors and outcome of no-reflow post primaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI and No-Reflow Phenomenon, run by Assiut University.
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 4 inclusion and 4 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mohammed Ahmed Abdelhmied (01147349160, abdelhmied22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SYNTAX Score (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery Score) (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. 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 NCT07706335, which also lists 7 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 16 Jul 2026.