Prediction of Cardiac Outcomes in Acute Coronary Syndrome Patients Using Triglyceride Glucose IndexNCT05158231
Value of Triglyceride Glucose Index in Prediction of Cardiac Outcomes in Patients With Acute Coronary Syndrome
An observational study of Prediction of Cardiac Outcomes in Acute Coronary Syndrome Patients Using Triglyceride Glucose Index, run by Sohag University at 1 site in Egypt.
Trial summary
Triglyceride glucose index and a reliable alternative marker of insulin resistance and an independent predictor of major adverse cardiovascular events (MACEs), which was defined as the composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediction of Cardiac Outcomes in Acute Coronary Syndrome Patients Using Triglyceride Glucose Index
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2021to 20 Jun 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted by acute coronary syndrome in coronary care unit
Who may be able to join
- acute coronary syndrome patients
Who cannot join
- With acute infectious disease, rheumatic disease, hematological disease, or neoplastic disease.
- With severe valvulopathy or cardiomyopathy
- Lacking clinical or follow-up data.
- suspected familial hypertriglyceridemia
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag university
Sohag, 82515
Mohamed Al Taha, Resident, 1097618777, mohamed011164@med.soh.edu.eg
About this study
Triglyceride glucose index and a reliable alternative marker of insulin resistance and an independent predictor of major adverse cardiovascular events (MACEs), which was defined as the composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure.
We hypothesis that there is a relation between prediction of MACE in acute coronary syndrome patients and between triglyceride glucose index.
Read the detailed description
Cardiovascular diseases, particularly coronary artery disease (CAD), is considered as a main cause of death and disability in the developed countries as its responsible for about 1 in every 5 deaths In the last few years.
Acute coronary syndrome (ACS), which is the most severe ischemic heart disease including Non-ST-elevation myocardial infarction (NSTEMI), ST-elevation MI (STEMI), and unstable angina has been one of the leading causes of death worldwide which leads to a large social and economic burden.
It has been well recognized that the development of (CAD) is driven by multiple factors including glycemic abnormality and lipid disorders.
Insulin resistance (IR) is a key metabolic abnormality leading to the development of T2DM, and recent studies have also found that it could independently predict the development of cardiovascular disease (CVD). Hyperinsulinemic-Euglycemic Clamp (HIEC), as the gold standard for the diagnosis of insulin resistance, is very difficult to be carried out in clinical work due to its difficulty of operation and equipment requirements.
Triglyceride and glucose index (TyG index) was one of the alternative methods for evaluating insulin resistance and is a novel marker Unlike the homeostasis model assessment and quantitative insulin sensitivity check index, insulin is not included in the TyG index and a reliable alternative marker of insulin resistance and an independent predictor of major adverse cardiovascular events (MACEs), which was defined as the composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure.
The TyG index was calculated as the ln (fasting triglyceride level [mg/dL] × fasting glucose level [mg/dL]/2) Normal cut-off values reported for the TyG in the literature are roughly around 4 and 8.
Aim of the work
To study the value of triglyceride glucose index as a short term predictor of MACE in diabetic and non diabetic patients presented by Acute coronary syndrome.
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride glucose index
Prediction of cardiac outcomes in acute coronary syndrome patients
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start20 Dec 2021 (estimated)
- Primary completion20 May 2022 (estimated)
- Study completion20 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prediction of Cardiac Outcomes in Acute Coronary Syndrome Patients Using Triglyceride Glucose IndexStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Taha, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158231
- Sponsor's protocol ID
- ethics@med.sohag.edu.eg
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang L, Cong HL, Zhang JX, Hu YC, Wei A, Zhang YY, Yang H, Ren LB, Qi W, Li WY, Zhang R, Xu JH. Triglyceride-glucose index predicts adverse cardiovascular events in patients with diabetes and acute coronary syndrome. Cardiovasc Diabetol. 2020 Jun 13;19(1):80. doi: 10.1186/s12933-020-01054-z.
PubMed 32534586
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Triglyceride Glucose Index in Prediction of Cardiac Outcomes in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05158231
- Acronym / sponsor ID
- ethics@med.sohag.edu.eg
- Conditions
- Prediction of Cardiac Outcomes in Acute Coronary Syndrome Patients Using Triglyceride Glucose Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (estimated)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 15 Dec 2021 (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.
Triglyceride glucose index and a reliable alternative marker of insulin resistance and an independent predictor of major adverse cardiovascular events (MACEs), which was defined as the composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure.
We hypothesis that there is a relation between prediction of MACE in acute coronary syndrome patients and between triglyceride glucose index.
Detailed description
Cardiovascular diseases, particularly coronary artery disease (CAD), is considered as a main cause of death and disability in the developed countries as its responsible for about 1 in every 5 deaths In the last few years.
Acute coronary syndrome (ACS), which is the most severe ischemic heart disease including Non-ST-elevation myocardial infarction (NSTEMI), ST-elevation MI (STEMI), and unstable angina has been one of the leading causes of death worldwide which leads to a large social and economic burden.
It has been well recognized that the development of (CAD) is driven by multiple factors including glycemic abnormality and lipid disorders.
Insulin resistance (IR) is a key metabolic abnormality leading to the development of T2DM, and recent studies have also found that it could independently predict the development of cardiovascular disease (CVD). Hyperinsulinemic-Euglycemic Clamp (HIEC), as the gold standard for the diagnosis of insulin resistance, is very difficult to be carried out in clinical work due to its difficulty of operation and equipment requirements.
Triglyceride and glucose index (TyG index) was one of the alternative methods for evaluating insulin resistance and is a novel marker Unlike the homeostasis model assessment and quantitative insulin sensitivity check index, insulin is not included in the TyG index and a reliable alternative marker of insulin resistance and an independent predictor of major adverse cardiovascular events (MACEs), which was defined as the composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure.
The TyG index was calculated as the ln (fasting triglyceride level [mg/dL] × fasting glucose level [mg/dL]/2) Normal cut-off values reported for the TyG in the literature are roughly around 4 and 8.
Aim of the work
To study the value of triglyceride glucose index as a short term predictor of MACE in diabetic and non diabetic patients presented by Acute coronary syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted by acute coronary syndrome in coronary care unit
Key inclusion criteria (1 listed)
- acute coronary syndrome patients
Key exclusion criteria (4 listed)
- With acute infectious disease, rheumatic disease, hematological disease, or neoplastic disease.
- With severe valvulopathy or cardiomyopathy
- Lacking clinical or follow-up data.
- suspected familial hypertriglyceridemia
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
Triglyceride glucose index
Time frame: 6months
Prediction of cardiac outcomes in acute coronary syndrome patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Background: PubMed 32534586Wang L, Cong HL, Zhang JX, Hu YC, Wei A, Zhang YY, Yang H, Ren LB, Qi W, Li WY, Zhang R, Xu JH. Triglyceride-glucose index predicts adverse cardiovascular events in patients with diabetes and acute coronary syndrome. Cardiovasc Diabetol. 2020 Jun 13;19(1):80. doi: 10.1186/s12933-020-01054-z.
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. This study is not recruiting at the moment.
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 Prediction of Cardiac Outcomes in Acute Coronary Syndrome Patients Using Triglyceride Glucose Index, run by Sohag 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 1 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: status not confirmed, as of the sponsor's last update on 15 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Al Taha, Resident (1097618777, mohamed011164@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglyceride glucose index (time frame: 6months). 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 NCT05158231, which also lists 1 linked publication.
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 Dec 2021.