Coronary Artery DiseaseNCT06452121
TyG Index as a Marker to Predict Severity of Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Assiut University.
Trial summary
Triglyceride glucose (TyG) index is a novel marker, which has been demonstrated to have a high sensitivity and specificity in identifying metabolic syndrome . Previous studies have shown that TyG index is associated with carotid atherosclerosis, coronary artery calcification and high risk of CVD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- triglyceride glucose index
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2025
- 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: Adult patients above 18 years old presenting with either with ACS undergoing coronary angiography or Ischemic heart disease patients undergoing elective coronary angiography.
Who may be able to join
- Adult patients above 18 years old presenting with either with ACS undergoing coronary angiography or Ischemic heart disease patients undergoing elective coronary angiography.
Who cannot join
- Pregnant or lactating women
- Patients with previous intravenous thrombolysis,
- Long -term use of statins or other lipid-regulating drugs
- Myocarditis
Trial locations and contacts
No sites are listed yet.
Alaa Abdelmonem contact
About this study
Official title: Triglyceride-glucose Index as a Marker to Predict Severity of Coronary Artery Disease
Triglyceride glucose (TyG) index is a novel marker, which has been demonstrated to have a high sensitivity and specificity in identifying metabolic syndrome . Previous studies have shown that TyG index is associated with carotid atherosclerosis, coronary artery calcification and high risk of CVD.
This study aims to predict severity of CAD using TyG index and its correlation to coronary angiography findings.
Read the detailed description
Coronary artery disease (CAD) is characterized by vulnerable atherosclerotic plaque, which causes coronary stenosis and myocardial ischemia. The blockage of the blood vessel caused by the detachment of the endovascular plate leads to an acute CAD attack. Without timely intervention, this can be life-threatening for the patient. Currently, coronary angiography (CAG) is the reference standard for diagnosing CAD with inconclusive evidence to confirm the morbid state. Although it assesses the severity of coronary vascular occlusion, this technique is invasive and carries inherent risks.
Hypertriglyceridemia (HTG) is a common dyslipidemia and the association of triglyceride (TG) with CVD risk remains controversial . However, judging from a credible body of evidence, we can conclude that HTG is an independent risk factor of developing glucose metabolism disorders. Plasma TG levels are strongly associated with raised glucose levels because of the interactions between fat, muscle and function of pancreatic β-cells .
Moreover, accumulation of TG in the liver may cause fatty liver disease, which can increase the risk of type 2 diabetes mellitus (T2DM) . Prospective studies have revealed that plasma TG is an independent risk factor for developing T2DM . Additionally, it has been demonstrated that lowering TG, such as fibrates do, can significantly attenuate the process of developing insulin resistance . Furthermore, it also has been reported that both fasting glucose and TG within the high normal range may predict CVD risk . Hence, evaluating the joint value of TG and fasting glucose in patients with stable coronary artery disease (CAD) may be clinically in need.
Triglyceride glucose (TyG) index is a novel marker, which has been demonstrated to have a high sensitivity and specificity in identifying metabolic syndrome . Previous studies have shown that TyG index is associated with carotid atherosclerosis, coronary artery calcification and high risk of CVD.
Several studies demonstrated that the TyG index has a positive relevance with type 2 diabetes, Insulin resistence ,subclinical myocardial injury,and acute coronary syndrome (ACS). A higher TyG index correlates with a greater incidence of major adverse cardiovascular events in patients with diabetes and ACS, indicating its potential as an independent predictor for cardiovascular disease prognosis.
A recent large-scale prospective study suggested that the TyG index is an independent predictor for the progression of coronary artery calcification, especially in individuals without heavy coronary artery calcification at baseline . Moreover, an increased TyG index has been shown to be independently associated with higher risks of atherosclerotic cardiovascular diseases, including myocardial infarction, and worse prognosis in patients with ACS, irrespective of diabetes mellitus .
This study aims to predict severity of CAD using TyG index and its correlation to coronary angiography findings.
- Conditions
- Coronary Artery Disease
- Being tested
- triglyceride glucose index
- Keywords
- triglyceride-glucose index
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triglyceride glucose indexOther
The TyG index was calculated using the following equation: Ln [TG (mg/dL)×FPG (mg/dL) / 2].
CAD was referred to as at least one major coronary artery with≥50% stenosis evaluated by CAG
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | to know severity of coronary artery disease using Triglyceride glucose (TyG) index in diabetic patients comparing it with non diabetic Receives: Other: triglyceride glucose index | |
| Non diabetic patients | to know severity of coronary artery disease using Triglyceride glucose (TyG) index in non diabetic patients Receives: Other: triglyceride glucose index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predict severity of coronary artery disease change in Triglyceride glucose (TyG) index
Predict severity of coronary artery disease using Triglyceride glucose (TyG) index and its correlation to coronary angiography findings
Measured: cases during 1 year of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (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 Coronary Artery DiseaseStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mohamed Mohsen Abdelaziz, Assiut University
- Investigators
- Fatma M Abdelaziz, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452121
- Sponsor's protocol ID
- TyG index and CAD
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Geng X, Zhang X, Li X, Zhong C, Hou M. Triglyceride-glucose Index as a Valuable Marker to Predict Severity of Coronary Artery Disease: A Retrospective Cohort Study. Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241234320. doi: 10.1177/10760296241234320.
PubMed 38444211Jin JL, Cao YX, Wu LG, You XD, Guo YL, Wu NQ, Zhu CG, Gao Y, Dong QT, Zhang HW, Sun D, Liu G, Dong Q, Li JJ. Triglyceride glucose index for predicting cardiovascular outcomes in patients with coronary artery disease. J Thorac Dis. 2018 Nov;10(11):6137-6146. doi: 10.21037/jtd.2018.10.79.
PubMed 30622785
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triglyceride-glucose Index as a Marker to Predict Severity of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06452121
- Acronym / sponsor ID
- TyG index and CAD
- Conditions
- Coronary Artery Disease
- Keywords
- triglyceride-glucose index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 11 Jun 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.
Triglyceride glucose (TyG) index is a novel marker, which has been demonstrated to have a high sensitivity and specificity in identifying metabolic syndrome . Previous studies have shown that TyG index is associated with carotid atherosclerosis, coronary artery calcification and high risk of CVD.
This study aims to predict severity of CAD using TyG index and its correlation to coronary angiography findings.
Detailed description
Coronary artery disease (CAD) is characterized by vulnerable atherosclerotic plaque, which causes coronary stenosis and myocardial ischemia. The blockage of the blood vessel caused by the detachment of the endovascular plate leads to an acute CAD attack. Without timely intervention, this can be life-threatening for the patient. Currently, coronary angiography (CAG) is the reference standard for diagnosing CAD with inconclusive evidence to confirm the morbid state. Although it assesses the severity of coronary vascular occlusion, this technique is invasive and carries inherent risks.
Hypertriglyceridemia (HTG) is a common dyslipidemia and the association of triglyceride (TG) with CVD risk remains controversial . However, judging from a credible body of evidence, we can conclude that HTG is an independent risk factor of developing glucose metabolism disorders. Plasma TG levels are strongly associated with raised glucose levels because of the interactions between fat, muscle and function of pancreatic β-cells .
Moreover, accumulation of TG in the liver may cause fatty liver disease, which can increase the risk of type 2 diabetes mellitus (T2DM) . Prospective studies have revealed that plasma TG is an independent risk factor for developing T2DM . Additionally, it has been demonstrated that lowering TG, such as fibrates do, can significantly attenuate the process of developing insulin resistance . Furthermore, it also has been reported that both fasting glucose and TG within the high normal range may predict CVD risk . Hence, evaluating the joint value of TG and fasting glucose in patients with stable coronary artery disease (CAD) may be clinically in need.
Triglyceride glucose (TyG) index is a novel marker, which has been demonstrated to have a high sensitivity and specificity in identifying metabolic syndrome . Previous studies have shown that TyG index is associated with carotid atherosclerosis, coronary artery calcification and high risk of CVD.
Several studies demonstrated that the TyG index has a positive relevance with type 2 diabetes, Insulin resistence ,subclinical myocardial injury,and acute coronary syndrome (ACS). A higher TyG index correlates with a greater incidence of major adverse cardiovascular events in patients with diabetes and ACS, indicating its potential as an independent predictor for cardiovascular disease prognosis.
A recent large-scale prospective study suggested that the TyG index is an independent predictor for the progression of coronary artery calcification, especially in individuals without heavy coronary artery calcification at baseline . Moreover, an increased TyG index has been shown to be independently associated with higher risks of atherosclerotic cardiovascular diseases, including myocardial infarction, and worse prognosis in patients with ACS, irrespective of diabetes mellitus .
This study aims to predict severity of CAD using TyG index and its correlation to coronary angiography findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Other: triglyceride glucose indexto know severity of coronary artery disease using Triglyceride glucose (TyG) index in diabetic patients comparing it with non diabetic |
| Non diabetic patients | – | Other: triglyceride glucose indexto know severity of coronary artery disease using Triglyceride glucose (TyG) index in non diabetic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients above 18 years old presenting with either with ACS undergoing coronary angiography or Ischemic heart disease patients undergoing elective coronary angiography.
Key inclusion criteria (1 listed)
- Adult patients above 18 years old presenting with either with ACS undergoing coronary angiography or Ischemic heart disease patients undergoing elective coronary angiography.
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Patients with previous intravenous thrombolysis,
- Long -term use of statins or other lipid-regulating drugs
- Myocarditis
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 indexThe TyG index was calculated using the following equation: Ln [TG (mg/dL)×FPG (mg/dL) / 2]. CAD was referred to as at least one major coronary artery with≥50% stenosis evaluated by CAG | Other | Diabetic patients, Non diabetic patients |
Primary outcome
Predict severity of coronary artery disease change in Triglyceride glucose (TyG) index
Time frame: cases during 1 year of the study
Predict severity of coronary artery disease using Triglyceride glucose (TyG) index and its correlation to coronary angiography findings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 38444211Geng X, Zhang X, Li X, Zhong C, Hou M. Triglyceride-glucose Index as a Valuable Marker to Predict Severity of Coronary Artery Disease: A Retrospective Cohort Study. Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241234320. doi: 10.1177/10760296241234320.
- Background: PubMed 30622785Jin JL, Cao YX, Wu LG, You XD, Guo YL, Wu NQ, Zhu CG, Gao Y, Dong QT, Zhang HW, Sun D, Liu G, Dong Q, Li JJ. Triglyceride glucose index for predicting cardiovascular outcomes in patients with coronary artery disease. J Thorac Dis. 2018 Nov;10(11):6137-6146. doi: 10.21037/jtd.2018.10.79.
- 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. This study is not recruiting at the moment.
Alaa Abdelmonem contact
Fatma M Abdelaziz study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, 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 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 5 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma M Abdelaziz (01001881973, fatmamohsen9292@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predict severity of coronary artery disease change in Triglyceride glucose (TyG) index (time frame: cases during 1 year of the study). 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 NCT06452121, 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 5 Aug 2024.