Coronary Artery Disease With Myocardial InfarctionNCT04004832
Comparison of the Severity of Coronary Atherosclerosis With Tissue Compliance in Patients Within First Degree Relatives
An observational study of Coronary Artery Disease With Myocardial Infarction, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study research the similarity of coronary artery lesions according to HLA tissue compatibility in fisrt degree relatives of the patients who just admitted clinic as Acute coronary syndrome and underwent angiyography before . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease With Myocardial Infarction
- What is being tested?
- there is not any intervention procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2020to 1 Jan 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * male or female with age between 18-70 * hospital admission due to acute coronary syndrome with first degree relative history who had coronary angiyography before
Who may be able to join
- male or female with age between 18-70
- hospital admission due to acute coronary syndrome with first degree relative history who had coronary angiyography before
Who cannot join
- first degree relative without any angiyography history before for patients who admitted as acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zeki Çetinkaya
Kayseri, Melikgazi, 38200
Zeki Çetinkaya, +90 5393165950, zcetinkaya@erciyes.edu.tr
About this study
Official title: Comparison of the Severity and Prevalence of Coronary Atherosclerosis With Tissue Compliance (HLA Similarity ) in Patients Within First Degree Relatives
This study research the similarity of coronary artery lesions according to HLA tissue compatibility in fisrt degree relatives of the patients who just admitted clinic as Acute coronary syndrome and underwent angiyography before .
Read the detailed description
Coronary artery disease (CAD), which is mainly caused by atherosclerosis, is the most prevalent illness and the leading cause of death worldwide. Increasing evidence suggests that inflammation plays a primordial role in atherogenesis and is closely associated with the major histocompatibility complex (MHC) (human leukocyte antigen [HLA] in humans) molecules. HLA genes are located in 6p21.3, the proteins encoded by these HLA genes have a major role to play in antigen presentation and inflammatory pathways. HLA involvement in inflammation is mainly associated with the HLA-dependent activation of T cells. studies reported that the susceptibility to CAD is related with the polymorphisms in HLA-DRB1. The above evidence indicates that the polymorphisms in HLA class II are associated with the risk of CAD . This study research investigate three objects , firstly what is the similarity of the coronary artery lesions according to the compatability of HLA alleles between the first degree relatives who went angiography before , secondly is there any relation between HLA subtype allels and the coronary artery (RCA ?LAD ? ,CX? and can such a relation be responsible from the lesions in this artery ,finally is there any relation between HLA subtypes and turkish race coronary artery disease
- Being tested
- there is not any intervention procedure
- Medical subject headings
- Coronary Artery Disease, Autosomal Dominant, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is not any intervention procedureDiagnostic test
there is not any intervention procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
relation between HLA subgroups and severity and prevelance of coronary artery lesions
the hla similarity of two sibling patient %80 and the military syntax score %97,7
Measured: 20 MAY 2019 - 30 MAY 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start18 Sep 2020 (estimated)
- Primary completion7 Dec 2020 (estimated)
- Study completion1 Jan 2021 (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 Disease With Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Family based
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeki Çetinkaya, TC Erciyes University
- Investigators
- Zeki Çetinkaya, Study director, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004832
- Sponsor's protocol ID
- 2018/543
- Status last verified
- Sep 2020
- First submitted
- 28 May 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xiong Y, Wang L, Mo P, Huang G, Li A, Chai R, Lin X, Zhong Y, Liu B, Ou W, Liu B, Liu SM. Association between HLA-DQB1 alleles and susceptibility to coronary artery disease in Southern Han Chinese. Hum Immunol. 2017 Sep;78(9):540-546. doi: 10.1016/j.humimm.2017.06.003. Epub 2017 Jun 15.
PubMed 28624488
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Severity and Prevalence of Coronary Atherosclerosis With Tissue Compliance (HLA Similarity ) in Patients Within First Degree Relatives
- ClinicalTrials.gov ID
- NCT04004832
- Acronym / sponsor ID
- 2018/543
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 18 Sep 2020 (estimated)
- Primary completion
- 7 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 2 Jul 2019 (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 study research the similarity of coronary artery lesions according to HLA tissue compatibility in fisrt degree relatives of the patients who just admitted clinic as Acute coronary syndrome and underwent angiyography before .
Detailed description
Coronary artery disease (CAD), which is mainly caused by atherosclerosis, is the most prevalent illness and the leading cause of death worldwide. Increasing evidence suggests that inflammation plays a primordial role in atherogenesis and is closely associated with the major histocompatibility complex (MHC) (human leukocyte antigen [HLA] in humans) molecules. HLA genes are located in 6p21.3, the proteins encoded by these HLA genes have a major role to play in antigen presentation and inflammatory pathways. HLA involvement in inflammation is mainly associated with the HLA-dependent activation of T cells. studies reported that the susceptibility to CAD is related with the polymorphisms in HLA-DRB1. The above evidence indicates that the polymorphisms in HLA class II are associated with the risk of CAD . This study research investigate three objects , firstly what is the similarity of the coronary artery lesions according to the compatability of HLA alleles between the first degree relatives who went angiography before , secondly is there any relation between HLA subtype allels and the coronary artery (RCA ?LAD ? ,CX? and can such a relation be responsible from the lesions in this artery ,finally is there any relation between HLA subtypes and turkish race coronary artery disease
Study design
- Observational model
- Family based
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * male or female with age between 18-70 * hospital admission due to acute coronary syndrome with first degree relative history who had coronary angiyography before
Key inclusion criteria (2 listed)
- male or female with age between 18-70
- hospital admission due to acute coronary syndrome with first degree relative history who had coronary angiyography before
Key exclusion criteria (1 listed)
- first degree relative without any angiyography history before for patients who admitted as acute coronary syndrome
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 |
|---|---|---|
| there is not any intervention procedurethere is not any intervention procedure | Diagnostic test | – |
Primary outcome
relation between HLA subgroups and severity and prevelance of coronary artery lesions
Time frame: 20 MAY 2019 - 30 MAY 2019
the hla similarity of two sibling patient %80 and the military syntax score %97,7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 28624488Xiong Y, Wang L, Mo P, Huang G, Li A, Chai R, Lin X, Zhong Y, Liu B, Ou W, Liu B, Liu SM. Association between HLA-DQB1 alleles and susceptibility to coronary artery disease in Southern Han Chinese. Hum Immunol. 2017 Sep;78(9):540-546. doi: 10.1016/j.humimm.2017.06.003. Epub 2017 Jun 15.
- 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.
Zeki Çetinkaya study director
Doctor
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 Coronary Artery Disease With Myocardial Infarction, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 1 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 21 Sep 2020. 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 Turkey (Türkiye). 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 Zeki Çetinkaya (+905393165950, zeki2387@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relation between HLA subgroups and severity and prevelance of coronary artery lesions (time frame: 20 MAY 2019 - 30 MAY 2019). 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 NCT04004832, 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 21 Sep 2020.