Coronary Artery DiseaseNCT05369702
Association of Coronary Artery Disease With Lewis and ABO Blood Group Phenotypes
An observational study of Coronary Artery Disease, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial summary
Primary objective- To study the association of Lewis antigen and A, B, O blood group phenotypes with coronary artery disease patients attending the tertiary care hospital in Kerala. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 210 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2019to 30 Apr 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 70 cases attending the Cardiology department who satisfy the inclusion and exclusion criteria were taken as cases. 140 (age and gender-matched) healthy blood donors who were eligible to donate blood as per the inclusion and exclusion criteria of Drugs and Cosmetics Rules, 1945 were taken as controls.
Who may be able to join
- Patients in the age group of 30-55 years at the time of data collection diagnosed with coronary artery disease based on positive changes in coronary angiogram (more than 70% coronary stenosis)
Who cannot join
- Patients with other systemic illnesses like malignancy, autoimmune diseases.
- Patients who were not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
India1 site
Jubilee Mission Medical College & Research Institute
Thrissur, Kerala, 680005
About this study
Official title: Association of Coronary Artery Disease With Lewis and ABO Blood Group Phenotypes- A Case Control Study
Primary objective- To study the association of Lewis antigen and A, B, O blood group phenotypes with coronary artery disease patients attending the tertiary care hospital in Kerala.
The secondary objective-To find the association of Lewis antigen and A, B, O blood group phenotypes with smoking, alcohol use, diabetes, hypertension and dyslipidemia.
A case-control study to compare the prevalence of Lewis(a-b-) blood group among confirmed cardiac cases with the prevalence of the same among the general population and thereby find out if individuals with Lewis(a-b-) are more at risk of developing coronary artery disease. This may provide an economical and simple method for identifying subjects at increased risk for coronary artery disease and subsequently lead to more focused preventive measures and eventually to a specific treatment.
- Conditions
- Coronary Artery Disease
- Keywords
- ABO blood group system, Lewis negative phenotype, coronary artery disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CASE(coronary artery disease) | Patients with confirmed coronary artery disease | |
| CONTROL | People without coronary artery disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Lewis and ABO blood group phenotypes in cases and controls.
Prevalence Lewis and ABO phenotype in cases will be compared to prevalence of the same in controls.
Measured: Lewis and ABO phenotype of the study participants was determined immediately after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Nov 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sree Raj V, Jubilee Mission Medical College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369702
- Sponsor's protocol ID
- 47/19/IEC/JMMC&RI
- Status last verified
- May 2022
- First submitted
- 29 Apr 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Coronary Artery Disease With Lewis and ABO Blood Group Phenotypes- A Case Control Study
- ClinicalTrials.gov ID
- NCT05369702
- Acronym / sponsor ID
- 47/19/IEC/JMMC&RI
- Conditions
- Coronary Artery Disease
- Keywords
- ABO blood group system, Lewis negative phenotype, coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 11 May 2022 (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.
Primary objective- To study the association of Lewis antigen and A, B, O blood group phenotypes with coronary artery disease patients attending the tertiary care hospital in Kerala.
The secondary objective-To find the association of Lewis antigen and A, B, O blood group phenotypes with smoking, alcohol use, diabetes, hypertension and dyslipidemia.
A case-control study to compare the prevalence of Lewis(a-b-) blood group among confirmed cardiac cases with the prevalence of the same among the general population and thereby find out if individuals with Lewis(a-b-) are more at risk of developing coronary artery disease. This may provide an economical and simple method for identifying subjects at increased risk for coronary artery disease and subsequently lead to more focused preventive measures and eventually to a specific treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASE(coronary artery disease) | – | –Patients with confirmed coronary artery disease |
| CONTROL | – | –People without coronary artery disease |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 70 cases attending the Cardiology department who satisfy the inclusion and exclusion criteria were taken as cases. 140 (age and gender-matched) healthy blood donors who were eligible to donate blood as per the inclusion and exclusion criteria of Drugs and Cosmetics Rules, 1945 were taken as controls.
Key inclusion criteria (1 listed)
- Patients in the age group of 30-55 years at the time of data collection diagnosed with coronary artery disease based on positive changes in coronary angiogram (more than 70% coronary stenosis)
Key exclusion criteria (2 listed)
- Patients with other systemic illnesses like malignancy, autoimmune diseases.
- Patients who were not willing to participate in 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
Prevalence of Lewis and ABO blood group phenotypes in cases and controls.
Time frame: Lewis and ABO phenotype of the study participants was determined immediately after sample collection
Prevalence Lewis and ABO phenotype in cases will be compared to prevalence of the same in controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
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 2 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: finished, as of the sponsor's last update on 16 May 2022. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Lewis and ABO blood group phenotypes in cases and controls. (time frame: Lewis and ABO phenotype of the study participants was determined immediately after sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2022.