NCT05369702

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

April 29, 2022

Last Update Submit

May 10, 2022

Conditions

Keywords

ABO blood group systemLewis negative phenotypecoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Lewis and ABO phenotype of the study participants was determined immediately after sample collection

Study Arms (2)

CASE(coronary artery disease)

Patients with confirmed coronary artery disease

CONTROL

People without coronary artery disease

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \- 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)

You may not qualify if:

  • Patients with other systemic illnesses like malignancy, autoimmune diseases.
  • Patients who were not willing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jubilee Mission Medical College & Research Institute

Thrissur, Kerala, 680005, India

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 11, 2022

Study Start

November 1, 2019

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

May 16, 2022

Record last verified: 2022-05

Locations