Major Cardiovascular EventsNCT06066177
Impact of Triglyceride-Glucose Index on Cardiovascular Outcomes in Patients Presented With MINOCA
An observational study of Major Cardiovascular Events, run by Assiut University.
Trial summary
This work was designed to explore the role of the triglyceride-glucose (TyG) index in the prediction of cardiovascular outcomes in Patients Presented with myocardial infarction with nonobstructive coronary arteries. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Major Cardiovascular Events
- What is being tested?
- Triglyceride glucose index TyG
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2024to 1 Oct 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 Up to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Myocardial infarction patients who were underwent PPCI and the coronary angiography showing insignificant lesions (stenosis less than 50% )
Who may be able to join
- All patients; diagnosed with myocardial infarction with nonobstructive coronary arteries (MINOCA)
- clinical symptoms
- ECG : ischemic changes with or without ST segment elevation
- Echocardiograpy : segmental wall motion abnormalities (SWMA)
- positive cardiac enzymes
- Coronary angiography: insignificant lesions ,the absence of culprit obstructive coronary artery disease (epicardial coronary artery stenosis ≥50%)
Who cannot join
- All non confirmed diagnosis of MINOCA
- cardiac
- non-ischemic cardiomyopathies
- non-cardiac
- pulmonary embolism
- stroke
- sepsis
- ARDS
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: Impact of Triglyceride-Glucose Index on Cardiovascular Outcomes in Patients Presented With Myocardial Infarction With Nonobstructive Coronary Arteries
This work was designed to explore the role of the triglyceride-glucose (TyG) index in the prediction of cardiovascular outcomes in Patients Presented with myocardial infarction with nonobstructive coronary arteries.
Read the detailed description
Acute myocardial infarction (AMI) remains the leading causes of high morbidity and mortality worldwide . Recently, a distinct population with myocardial infarction with nonobstructive coronary arteries (MINOCA) has been increasingly recognized because of the widespread use of coronary angiography. MINOCA occurs in 5%-10% of all AMI and they are younger and more often women compared to patients with AMI and obstructive coronary artery disease (CAD). The underlying causes of MINOCA are manifold and may include plaque rupture or erosion, thromboembolism, coronary spasm, spontaneous dissection, microvascular dysfunction and supply/demand mismatch. Some non-ischemic diseases such as myocarditis may also mimic the presentation of MINOCA . Of note, several studies have found that the prognosis of MINOCA is not trivial and patients are still at considerable risks for long-term adverse cardiovascular (CV) events despite the optimal secondary prevention treatments . Thus, it is of necessity and profound implications to find potential residual risk factors and improve prognosis in MINOCA population.
Insulin resistance (IR), a critical mechanism of the pathogenesis of diabetes, not only contributes to the development of cardiovascular diseases (CVD), but also significantly correlates with adverse CV outcomes. Additionally, IR often coexists with obesity, hypertension, and dyslipidemia , and all of these are well-known risk factors of CVD. Recently, the triglyceride-glucose (TyG) index derived from fasting triglyceride (TG) and fasting blood glucose (FBG) levels has been proposed as a new and valid surrogate indicator of IR . Till now, many studies have found that the TyG index is positively correlated with metabolic disorders, arterial stiffness , carotid atherogenesis , coronary artery calcification , and subclinical or symptomatic CAD. Moreover, growing evidence has showed that the TyG index is an independent predictor of poor CV outcomes in general population and in different cohorts with CAD, including patients with AMI or acute coronary syndrome (ACS) with or without diabetes
- Conditions
- Major Cardiovascular Events
- Being tested
- Triglyceride glucose index TyG
- Keywords
- Triglyceride glucose index Myocardial infarction MINOCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triglyceride glucose index TyGDiagnostic test
Triglyceride glucose index is an indicator of insulin resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiovascular events (MACE)
including
- all-cause death,
- reinfarction,
- stroke,
- re-intervention
- hospitalization for unstable angina or heart failure)
Measured: along one year follow up .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start20 Jan 2024 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Cardiovascular EventsStudies 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, Ahmed Gamal Thabit Mohamed, Assiut University
- Investigators
- Ayman khairy Mohamed Hassan, Principal investigator, Cardiology departmentKhaled Mohamed Abdullah Mohamed, Principal investigator, Cardiology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066177
- Sponsor's protocol ID
- TyG index and MINOCA
- Status last verified
- Jan 2024
- First submitted
- 27 Sep 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao S, Ma W, Huang S, Lin X, Yu M. Impact of triglyceride-glucose index on long-term cardiovascular outcomes in patients with myocardial infarction with nonobstructive coronary arteries. Nutr Metab Cardiovasc Dis. 2021 Oct 28;31(11):3184-3192. doi: 10.1016/j.numecd.2021.07.027. Epub 2021 Aug 4.
PubMed 34511291Zhao X, Wang Y, Chen R, Li J, Zhou J, Liu C, Zhou P, Sheng Z, Chen Y, Song L, Zhao H, Yan H. Triglyceride glucose index combined with plaque characteristics as a novel biomarker for cardiovascular outcomes after percutaneous coronary intervention in ST-elevated myocardial infarction patients: an intravascular optical coherence tomography study. Cardiovasc Diabetol. 2021 Jun 28;20(1):131. doi: 10.1186/s12933-021-01321-7.
PubMed 34183007
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Triglyceride-Glucose Index on Cardiovascular Outcomes in Patients Presented With Myocardial Infarction With Nonobstructive Coronary Arteries
- ClinicalTrials.gov ID
- NCT06066177
- Acronym / sponsor ID
- TyG index and MINOCA
- Conditions
- Major Cardiovascular Events
- Keywords
- Triglyceride glucose index Myocardial infarction MINOCA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 4 Oct 2023 (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 work was designed to explore the role of the triglyceride-glucose (TyG) index in the prediction of cardiovascular outcomes in Patients Presented with myocardial infarction with nonobstructive coronary arteries.
Detailed description
Acute myocardial infarction (AMI) remains the leading causes of high morbidity and mortality worldwide . Recently, a distinct population with myocardial infarction with nonobstructive coronary arteries (MINOCA) has been increasingly recognized because of the widespread use of coronary angiography. MINOCA occurs in 5%-10% of all AMI and they are younger and more often women compared to patients with AMI and obstructive coronary artery disease (CAD). The underlying causes of MINOCA are manifold and may include plaque rupture or erosion, thromboembolism, coronary spasm, spontaneous dissection, microvascular dysfunction and supply/demand mismatch. Some non-ischemic diseases such as myocarditis may also mimic the presentation of MINOCA . Of note, several studies have found that the prognosis of MINOCA is not trivial and patients are still at considerable risks for long-term adverse cardiovascular (CV) events despite the optimal secondary prevention treatments . Thus, it is of necessity and profound implications to find potential residual risk factors and improve prognosis in MINOCA population.
Insulin resistance (IR), a critical mechanism of the pathogenesis of diabetes, not only contributes to the development of cardiovascular diseases (CVD), but also significantly correlates with adverse CV outcomes. Additionally, IR often coexists with obesity, hypertension, and dyslipidemia , and all of these are well-known risk factors of CVD. Recently, the triglyceride-glucose (TyG) index derived from fasting triglyceride (TG) and fasting blood glucose (FBG) levels has been proposed as a new and valid surrogate indicator of IR . Till now, many studies have found that the TyG index is positively correlated with metabolic disorders, arterial stiffness , carotid atherogenesis , coronary artery calcification , and subclinical or symptomatic CAD. Moreover, growing evidence has showed that the TyG index is an independent predictor of poor CV outcomes in general population and in different cohorts with CAD, including patients with AMI or acute coronary syndrome (ACS) with or without diabetes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Myocardial infarction patients who were underwent PPCI and the coronary angiography showing insignificant lesions (stenosis less than 50% )
Key inclusion criteria (6 listed)
- All patients; diagnosed with myocardial infarction with nonobstructive coronary arteries (MINOCA)
- clinical symptoms
- ECG : ischemic changes with or without ST segment elevation
- Echocardiograpy : segmental wall motion abnormalities (SWMA)
- positive cardiac enzymes
Key exclusion criteria (8 listed)
- All non confirmed diagnosis of MINOCA
- cardiac
- non-cardiac
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 |
|---|---|---|
| Triglyceride glucose index TyGTriglyceride glucose index is an indicator of insulin resistance | Diagnostic test | – |
Primary outcome
Incidence of major adverse cardiovascular events (MACE)
Time frame: along one year follow up .
including * all-cause death, * reinfarction, * stroke, * re-intervention * hospitalization for unstable angina or heart failure)
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 30 Jan 2024.
- Background: PubMed 34511291Gao S, Ma W, Huang S, Lin X, Yu M. Impact of triglyceride-glucose index on long-term cardiovascular outcomes in patients with myocardial infarction with nonobstructive coronary arteries. Nutr Metab Cardiovasc Dis. 2021 Oct 28;31(11):3184-3192. doi: 10.1016/j.numecd.2021.07.027. Epub 2021 Aug 4.
- Background: PubMed 34183007Zhao X, Wang Y, Chen R, Li J, Zhou J, Liu C, Zhou P, Sheng Z, Chen Y, Song L, Zhao H, Yan H. Triglyceride glucose index combined with plaque characteristics as a novel biomarker for cardiovascular outcomes after percutaneous coronary intervention in ST-elevated myocardial infarction patients: an intravascular optical coherence tomography study. Cardiovasc Diabetol. 2021 Jun 28;20(1):131. doi: 10.1186/s12933-021-01321-7.
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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.
Ayman khairy Mohamed Hassan principal investigator
Cardiology department
Khaled Mohamed Abdullah Mohamed principal investigator
Cardiology department
Questions about this trial
What is this clinical trial studying?
An observational study of Major Cardiovascular Events, 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 6 inclusion and 8 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 30 Jan 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 Ahmed Gamal Thabit Mohamed (01065476011, ahmedgamal54011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiovascular events (MACE) (time frame: along one year follow up .). 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 NCT06066177, which also lists 2 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 30 Jan 2024.