NCT06675890

Brief Summary

This study is aimed at correlating serum homocysteine level with coronary artery disease (CAD) and related in-hospital mortality. A cross section of patients from age 18 years and above will be studied for homocysteine level and analyzed for the above mentioned correlation. The study was approved by hospital ethical review board as mentioned. An informed written consent was obtained before the patients' recruitment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
381

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

November 1, 2024

Last Update Submit

November 5, 2024

Conditions

Keywords

Coronary Artery DiseaseSerum HomocysteineIn-hospital Mortality

Outcome Measures

Primary Outcomes (1)

  • Homocysteine levels and its correlation with the type of coronary artery disease.

    Higher homocysteine levels in ST segment myocardial infarction (STEMI) and non ST segment myocardial infarction (NSTEMI) as compared to Angina.

    2 years

Secondary Outcomes (1)

  • Risk factors for coronary artery disease

    2 years

Study Arms (1)

patients having coronary arterial disease.

patients with different types of coronary arterial disease and their homocysteine levels.

Diagnostic Test: serum homocysteine

Interventions

serum homocysteineDIAGNOSTIC_TEST

serum homocysteine is associated with atherosclerosis and vascular diseases.

patients having coronary arterial disease.

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of all ethnicities and both genders from 25 to 80 years with coronary artery disease.

You may qualify if:

  • Coronary artery disease patients from age 25 years to 80 years.

You may not qualify if:

  • Grade 4 chronic kidney disease patients
  • Chronic liver disease patients
  • Pregnant and lactating females
  • Patients on vitamin supplements
  • Patients with genetic homocysteine abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayatabad Medical Complex

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (5)

  • Hankey GJ, Eikelboom JW. Homocysteine and vascular disease. Lancet. 1999 Jul 31;354(9176):407-13. doi: 10.1016/S0140-6736(98)11058-9.

    PMID: 10437885BACKGROUND
  • Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med. 2000 Mar 23;342(12):836-43. doi: 10.1056/NEJM200003233421202.

    PMID: 10733371BACKGROUND
  • Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.

    PMID: 33309175BACKGROUND
  • Wong ND. Epidemiological studies of CHD and the evolution of preventive cardiology. Nat Rev Cardiol. 2014 May;11(5):276-89. doi: 10.1038/nrcardio.2014.26. Epub 2014 Mar 25.

    PMID: 24663092BACKGROUND
  • Khan MA, Hashim MJ, Mustafa H, Baniyas MY, Al Suwaidi SKBM, AlKatheeri R, Alblooshi FMK, Almatrooshi MEAH, Alzaabi MEH, Al Darmaki RS, Lootah SNAH. Global Epidemiology of Ischemic Heart Disease: Results from the Global Burden of Disease Study. Cureus. 2020 Jul 23;12(7):e9349. doi: 10.7759/cureus.9349.

    PMID: 32742886BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Himayat Ullah, FCPS

    Shaqra University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor/Dr

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 5, 2024

Study Start

March 1, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to confidentiality.

Locations