STEMI - ST Elevation Myocardial InfarctionNCT06642259
Correlation Between Triglyceride Glucose Index and Residual SYNTAX Score in STEMI Patients Undergoing PPCI
An observational study of STEMI - ST Elevation Myocardial Infarction, run by Assiut University.
Trial summary
The goal of this study To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI. 2. Impact of both TyG index and RSS in STEMI patients undergoing PPCI on LV EF recovery after 3 months using LV speckle tracking. 3. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to Dec 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with STEMI and will undergo PPCI and fulfilling our inclusion criteria over a period of 6 months will be enrolled in our study.
Who may be able to join
- All patient who are between 18 and 80 years old who present to our hospital (Assiut university heart hospital) with STEMI and eligible for primary PCI as treatment of choice according to guidelines, will be included in our study.
Who cannot join
- Patient who refuse to undergo revasculariztion using primary PCI.
- Patient who will die before withdraw of laboratory blood sample.
- Patient with previous PCI and/or CABG.
- Patient with underlying co-morbidity with life expectancy less than 1 year (end stage liver disease, end stage renal disease on regular dialysis, active malignancy).
- Patient with failed canalization of infarct related artery.
- Patient referred to CABG after angiography.
- Patient who is unconscious after cardiac arrest .
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
Official title: Correlation Between Triglyceride Glucose Index and Residual SYNTAX Score in ST-elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention
The goal of this study To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI.
- Impact of both TyG index and RSS in STEMI patients undergoing PPCI on LV EF recovery after 3 months using LV speckle tracking.
- Impact of RSS and TyG index in STEMI patients undergoing PPCI on short term MACE at 3 months duration.
Read the detailed description
ST-elevation myocardial infarction (STEMI) is known as a life-threatening complication of coronary artery disease (CAD) and it is one of the leading causes of death all over the world. Primary percutaneous coronary intervention (PPCI) of the culprit vessel in patients with STEMI is standard clinical practice .
At the time of PPCI, 40-65% of the patients exhibit one or more concomitant coronary lesions (i.e., multivessel disease (MVD)). The presence of narrowed coronaries other than those related to index ischemia in patients with STEMI is suggested as a feature associated with adverse clinical outcomes .
The recently developed residual SYNTAX Score (RSS) (developed 2012 and validated in 2013) is an objective, quantitative measure of the degree and complexity of residual stenosis after percutaneous coronary intervention (PCI) .It was developed to quantitatively assess the degree and complexity of residual stenoses, based on recalculating the SYNTAX score from coronary angiography after PCI . Higher RSS has been associated with worse outcome in patients undergoing angiography-mediated PCI .
Insulin resistance (IR) is an important risk factor for the development of CAD . It is defined as a state in which a greater than normal amount of insulin is required to elicit a quantitatively normal response .
Previous studies have shown an independent association between IR and CVD. IR is tightly associated with increased cardiovascular morbidity and mortality by adversely modifying well-established cardiovascular risk factors such as dyslipidemia and hypertension and by causing endothelial dysfunction .
- Being tested
- Echocardiography
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyRadiation
ECHO
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI
- To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies 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
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammad medhat elsayed hasan, Assiut University
- Investigators
- Salwa Roshdy, Pro, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642259
- Sponsor's protocol ID
- (TyG) index and SYNTAX
- Status last verified
- Oct 2024
- First submitted
- 18 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Triglyceride Glucose Index and Residual SYNTAX Score in ST-elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06642259
- Acronym / sponsor ID
- (TyG) index and SYNTAX
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Oct 2024 (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.
The goal of this study To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI.
- Impact of both TyG index and RSS in STEMI patients undergoing PPCI on LV EF recovery after 3 months using LV speckle tracking.
- Impact of RSS and TyG index in STEMI patients undergoing PPCI on short term MACE at 3 months duration.
Detailed description
ST-elevation myocardial infarction (STEMI) is known as a life-threatening complication of coronary artery disease (CAD) and it is one of the leading causes of death all over the world. Primary percutaneous coronary intervention (PPCI) of the culprit vessel in patients with STEMI is standard clinical practice .
At the time of PPCI, 40-65% of the patients exhibit one or more concomitant coronary lesions (i.e., multivessel disease (MVD)). The presence of narrowed coronaries other than those related to index ischemia in patients with STEMI is suggested as a feature associated with adverse clinical outcomes .
The recently developed residual SYNTAX Score (RSS) (developed 2012 and validated in 2013) is an objective, quantitative measure of the degree and complexity of residual stenosis after percutaneous coronary intervention (PCI) .It was developed to quantitatively assess the degree and complexity of residual stenoses, based on recalculating the SYNTAX score from coronary angiography after PCI . Higher RSS has been associated with worse outcome in patients undergoing angiography-mediated PCI .
Insulin resistance (IR) is an important risk factor for the development of CAD . It is defined as a state in which a greater than normal amount of insulin is required to elicit a quantitatively normal response .
Previous studies have shown an independent association between IR and CVD. IR is tightly associated with increased cardiovascular morbidity and mortality by adversely modifying well-established cardiovascular risk factors such as dyslipidemia and hypertension and by causing endothelial dysfunction .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with STEMI and will undergo PPCI and fulfilling our inclusion criteria over a period of 6 months will be enrolled in our study.
Key inclusion criteria (1 listed)
- All patient who are between 18 and 80 years old who present to our hospital (Assiut university heart hospital) with STEMI and eligible for primary PCI as treatment of choice according to guidelines, will be included in our study.
Key exclusion criteria (7 listed)
- Patient who refuse to undergo revasculariztion using primary PCI.
- Patient who will die before withdraw of laboratory blood sample.
- Patient with previous PCI and/or CABG.
- Patient with underlying co-morbidity with life expectancy less than 1 year (end stage liver disease, end stage renal disease on regular dialysis, active malignancy).
- Patient with failed canalization of infarct related artery.
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 |
|---|---|---|
| EchocardiographyECHO | Radiation | – |
Primary outcome
1. To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI
Time frame: baseline
1. To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI.
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 15 Oct 2024.
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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.
Salwa Roshdy, Pro study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI - ST Elevation Myocardial Infarction, 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 1 inclusion and 7 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 15 Oct 2024. 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 Mohammad Medhat, MD student (01157138440, mohammedmedhat1907@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.