Coronary Artery DiseaseNCT03146208
Role of Endothelial Biomarkers in Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease and Diabetes Mellitus, run by Assiut University.
Trial summary
Coronary artery disease is a contraction of the coronary arteries that prevent adequate blood supply to the heart muscle is called CAD. Usually caused by atherosclerosis, it may be advanced to the point where the heart muscle is injured due to lack of blood supply. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus, Cytomegalovirus Infections
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 20 Jan 2019
- How long will I take part?
- 11 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 25 to 55 years
- All sexes
- Adult
Study population: The patients will be selected from Cardiology Department in Assiut University Hospital, according to American Heart Association, patients with manifestation of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing) with or without T2DM. All patients with risk factors such as hypertension, hyperlipidemia and smokers. The sample size was calculated using EPi Info 2000, version 1.1.2 (Center for disease control and prevention, Atlanta, Georgia, USA) based on proportion of telomere shortening in normal subjects range from 0-1% and it is expected to be 14 % in patients with coronary artery disease (Daily News, American Heart Association, 2016) using 90% confidence interval and 80% power, the sample size is 54 cases of coronary artery disease and 54 control subjects (total 108).
Who may be able to join
- According to American Heart Association, patients with a manifestation of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing) with or without T2DM.
- All patients with risk factors such as hypertension, hyperlipidemia and smokers.
Who cannot join
- Psycological disorders
- Cancers.
- Strock.
- Acute and chronic inflammation and Autoimmune diseases were excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Biomarkers of Coronary Artery Diseases
Coronary artery disease is a contraction of the coronary arteries that prevent adequate blood supply to the heart muscle is called CAD. Usually caused by atherosclerosis, it may be advanced to the point where the heart muscle is injured due to lack of blood supply. Such damage may result in infarction, arrhythmias, and heart failure(1,2).
Telomeres are short in circulating leucocytes in patients with coronary artery disease but the precise mechanism is not well-known (3).
Read more
Telomere and telomerase are affected by cytomegalovirus (CMV) infection due to its effect on increasing the number of highly differentiated T cells that are characterized by shorter telomere length (TL) and lowered telomerase activity (TA). Both genetic and environmental factors have been connected with individual distinction in TL.Cardiovascular risk factors such as smoking, diabetes mellitus, hypertension, obesity, and stress have been considered to upsurge inflammation, oxidative stress, therefore accelerating TL shortening (1,2)
It has also been observed that telomere loss in type 2 diabetic patients contributes to oxidative stress and endoplasmic reticulum stress while telomere shortening has also been proposed that it can serve as an independent risk factor of T2DM and it can measure disease progression(4).
Moreover, telomeric length in peripheral blood mononuclear cells (PBMCs) is associated with the duration of disease and good glycemic control seems to be protective for telomeric loss (5).
Growth differentiation factor-15 (GDF-15) is a member of the transforming growth factor (TGF)-β superfamily. GDF-15, recently identified as one of the new cardioprotective cytokines. It is highly expressed in cardiomyocytes, adipocytes, macrophages, endothelial cells, and vascular smooth muscle cells in normal and pathological condition. GDF-15 increases during tissue injury and inflammatory states and is associated with cardiometabolic risk(6).
Dipeptidyl peptidase inhibitors (DPP4 -I) are called gliptins which increase the incretin levels and therefore prolong the post-prandial insulin action(7).
Diana et al reported that In type 2 diabetic patients, leukocyte telomere was significantly shorter than control groups and was significantly elongated after intervention by sitagliptin(8).
The common feature of all risk factors of CAD and T2DM imbalance between pro- and anti-oxidative factors in the organism with an increased production of reactive oxygen species (ROS).Nuclear factor erythroid-derived factor 2-related factor 2(Nrf2) is a family of transcription factors which plays an important role in protection against CVD and DM by regulating antioxidant enzymes in cells after ROS exposure (9).
In our study, we will propose a model, which would provide the basis to establish a marker for chronic reactivation of CMV and shed more light into the pathophysiology of CMV infection in patients with CAD in relation to GDF-15 and NrF2 and their implications on disease progression. Ultimately, this would then enable us to identify patients at risk and develop novel strategies for future treatment and prevention of heart diseases in our country. In light of our project research, the question arises whether telomere length could represent a marker of chronic CMV reactivation and uncertainty their length will be modified by the effect of DPP-4 or not?
Read the detailed description
- We are aiming to establish a marker for chronic reactivation and pathophysiology of CMV infection in patients with coronary artery disease.
- We will be able to answer whether there is a link between the seropositive CMV, telomere length, and CAD.
- We will correlate the seropositive CMV with telomere length, GDF-15 \& NRF2.
- We will detect the origin of our biomarkers by human umbilical vein endothelial cells(HUVECS).
- We will measure the effect of DPP4-I (on TL \& GDF-15 on cardiac cell line).
- We are looking to establish a new potential risk marker from our study, (GDF-15 \& NRF2) which could be tested in a larger cohort of patients. This would then enable us to identify CMV-seropositive patients at risk and develop novel strategies for future treatment and prevention.
- Keywords
- Growth differentiation factor-15, Dipeptidyl-peptidase inhibitors (DPP4 -I), Coronroy artery diseases
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery disease patients with type 2 DM | Coronary artery disease patients with type 2 diabetes (age 20-55 years). The present study will be carried on 25 patients attending to cardiology department with coronary artery disease with type 2 diabetes | |
| Coronary artery disease patients without type 2 DM | The present study will be carried on 29 patients attending to cardiology department with coronary artery disease without type 2 diabetes (age 20-55 years). | |
| Healthy control group | we will include 54 age-matched patients with normal angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of endothelial bio markers in patients with coronary artery disease
genetic expression of new bio markers in coronary artery diseases
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion15 Oct 2018 (estimated)
- Study completion20 Jan 2019 (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 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (estimated)
- Target duration
- 11 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Kamal Idriss, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146208
- Sponsor's protocol ID
- 17200057
- Status last verified
- May 2017
- First submitted
- 6 May 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Qi Nan W, Ling Z, Bing C. The influence of the telomere-telomerase system on diabetes mellitus and its vascular complications. Expert Opin Ther Targets. 2015 Jun;19(6):849-64. doi: 10.1517/14728222.2015.1016500. Epub 2015 Feb 13.
PubMed 25677239
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Coronary Artery Diseases
- ClinicalTrials.gov ID
- NCT03146208
- Acronym / sponsor ID
- 17200057
- Keywords
- Growth differentiation factor-15, Dipeptidyl-peptidase inhibitors (DPP4 -I), Coronroy artery diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 15 Oct 2018 (estimated)
- Study completion
- 20 Jan 2019 (estimated)
- First posted
- 9 May 2017 (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.
Coronary artery disease is a contraction of the coronary arteries that prevent adequate blood supply to the heart muscle is called CAD. Usually caused by atherosclerosis, it may be advanced to the point where the heart muscle is injured due to lack of blood supply. Such damage may result in infarction, arrhythmias, and heart failure(1,2).
Telomeres are short in circulating leucocytes in patients with coronary artery disease but the precise mechanism is not well-known (3).
Telomere and telomerase are affected by cytomegalovirus (CMV) infection due to its effect on increasing the number of highly differentiated T cells that are characterized by shorter telomere length (TL) and lowered telomerase activity (TA). Both genetic and environmental factors have been connected with individual distinction in TL.Cardiovascular risk factors such as smoking, diabetes mellitus, hypertension, obesity, and stress have been considered to upsurge inflammation, oxidative stress, therefore accelerating TL shortening (1,2)
It has also been observed that telomere loss in type 2 diabetic patients contributes to oxidative stress and endoplasmic reticulum stress while telomere shortening has also been proposed that it can serve as an independent risk factor of T2DM and it can measure disease progression(4).
Moreover, telomeric length in peripheral blood mononuclear cells (PBMCs) is associated with the duration of disease and good glycemic control seems to be protective for telomeric loss (5).
Growth differentiation factor-15 (GDF-15) is a member of the transforming growth factor (TGF)-β superfamily. GDF-15, recently identified as one of the new cardioprotective cytokines. It is highly expressed in cardiomyocytes, adipocytes, macrophages, endothelial cells, and vascular smooth muscle cells in normal and pathological condition. GDF-15 increases during tissue injury and inflammatory states and is associated with cardiometabolic risk(6).
Dipeptidyl peptidase inhibitors (DPP4 -I) are called gliptins which increase the incretin levels and therefore prolong the post-prandial insulin action(7).
Diana et al reported that In type 2 diabetic patients, leukocyte telomere was significantly shorter than control groups and was significantly elongated after intervention by sitagliptin(8).
The common feature of all risk factors of CAD and T2DM imbalance between pro- and anti-oxidative factors in the organism with an increased production of reactive oxygen species (ROS).Nuclear factor erythroid-derived factor 2-related factor 2(Nrf2) is a family of transcription factors which plays an important role in protection against CVD and DM by regulating antioxidant enzymes in cells after ROS exposure (9).
In our study, we will propose a model, which would provide the basis to establish a marker for chronic reactivation of CMV and shed more light into the pathophysiology of CMV infection in patients with CAD in relation to GDF-15 and NrF2 and their implications on disease progression. Ultimately, this would then enable us to identify patients at risk and develop novel strategies for future treatment and prevention of heart diseases in our country. In light of our project research, the question arises whether telomere length could represent a marker of chronic CMV reactivation and uncertainty their length will be modified by the effect of DPP-4 or not?
Detailed description
- We are aiming to establish a marker for chronic reactivation and pathophysiology of CMV infection in patients with coronary artery disease.
- We will be able to answer whether there is a link between the seropositive CMV, telomere length, and CAD.
- We will correlate the seropositive CMV with telomere length, GDF-15 \& NRF2.
- We will detect the origin of our biomarkers by human umbilical vein endothelial cells(HUVECS).
- We will measure the effect of DPP4-I (on TL \& GDF-15 on cardiac cell line).
- We are looking to establish a new potential risk marker from our study, (GDF-15 \& NRF2) which could be tested in a larger cohort of patients. This would then enable us to identify CMV-seropositive patients at risk and develop novel strategies for future treatment and prevention.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 11 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coronary artery disease patients with type 2 DM | – | –Coronary artery disease patients with type 2 diabetes (age 20-55 years). The present study will be carried on 25 patients attending to cardiology department with coronary artery disease with type 2 diabetes |
| Coronary artery disease patients without type 2 DM | – | –The present study will be carried on 29 patients attending to cardiology department with coronary artery disease without type 2 diabetes (age 20-55 years). |
| Healthy control group | – | –we will include 54 age-matched patients with normal angiogram |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- The patients will be selected from Cardiology Department in Assiut University Hospital, according to American Heart Association, patients with manifestation of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing) with or without T2DM. All patients with risk factors such as hypertension, hyperlipidemia and smokers. The sample size was calculated using EPi Info 2000, version 1.1.2 (Center for disease control and prevention, Atlanta, Georgia, USA) based on proportion of telomere shortening in normal subjects range from 0-1% and it is expected to be 14 % in patients with coronary artery disease (Daily News, American Heart Association, 2016) using 90% confidence interval and 80% power, the sample size is 54 cases of coronary artery disease and 54 control subjects (total 108).
Key inclusion criteria (2 listed)
- According to American Heart Association, patients with a manifestation of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing) with or without T2DM.
- All patients with risk factors such as hypertension, hyperlipidemia and smokers.
Key exclusion criteria (4 listed)
- Psycological disorders
- Cancers.
- Strock.
- Acute and chronic inflammation and Autoimmune diseases were excluded from the study.
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
Role of endothelial bio markers in patients with coronary artery disease
Time frame: two years
genetic expression of new bio markers in coronary artery diseases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Results publication: PubMed 25677239Qi Nan W, Ling Z, Bing C. The influence of the telomere-telomerase system on diabetes mellitus and its vascular complications. Expert Opin Ther Targets. 2015 Jun;19(6):849-64. doi: 10.1517/14728222.2015.1016500. Epub 2015 Feb 13.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Diabetes Mellitus, 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 2 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 9 May 2017. 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 Abdelrehim Mekii, PROF (0201008423366 ext. 2411988, meki202000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of endothelial bio markers in patients with coronary artery disease (time frame: two years). 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 NCT03146208, 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 9 May 2017.