Study Stopped
Ethical approval was not done. Hence the funding was withhold.
Effects of Homocysteine in Myocardial Infarction Patients in a Tertiary Care Hospital of Pakistan
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Raised plasma Homocysteine (Hcy) was 1st proposed as a cause of vascular pathology in patients with inherited disorders of Homocysteine metabolism.leading to the hypothesis that individuals with slight to moderate elevated levels of Homocysteine may have an increased hazard for vascular disease. As an amino acid with a reactive sulfhydryl group, homocysteine has been proposed to intermediate vascular inflammation and damage by stimulating oxidative stress secondary to reactive oxygen species accumulation. which in turn leads to an rise in cardiac and vascular disease risk by stimulating endothelial dysfunction, smooth muscle cell proliferation, and vascular calcification. Consistent with this hypothesis, hyperhomocysteinemia a has been associated with an increased risk for coronary heart disease (CHD), heart failure, atrial fibrillation, stroke, and mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
August 12, 2021
CompletedStudy Start
First participant enrolled
August 12, 2021
CompletedFirst Posted
Study publicly available on registry
August 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2021
CompletedSeptember 10, 2021
September 1, 2021
28 days
August 12, 2021
September 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Homocysteine
It a marker of cardiovascular diseases.
4th weeks
Erythrocyte sedimentation rate (ESR)
It a marker of cardiovascular diseases.
4th weeks
Study Arms (3)
Control Group
OTHERThe blood sample of 5ml was collected from the subjects via a sterile disposable 5ml syringe. The site for the blood collection was antecubital vein of the forearm, which was cleaned an alcoholic swab. The blood sample was shifted to assigned plain bottle container, where it was allowed to clot at room temperature. The serum sample was separated from the blood sample through a centrifugation process at a speed of 5000 revolutions per minute (rpm) for 15 minutes and stored frozen in another bottle container until the time for analysis
Non-diabetic cardiac
EXPERIMENTALThe blood sample of 5ml was collected from the subjects via a sterile disposable 5ml syringe. The site for the blood collection was antecubital vein of the forearm, which was cleaned an alcoholic swab. The blood sample was shifted to assigned plain bottle container, where it was allowed to clot at room temperature. The serum sample was separated from the blood sample through a centrifugation process at a speed of 5000 revolutions per minute (rpm) for 15 minutes and stored frozen in another bottle container until the time for analysis
Diabetic cardiac
EXPERIMENTALThe blood sample of 5ml was collected from the subjects via a sterile disposable 5ml syringe. The site for the blood collection was antecubital vein of the forearm, which was cleaned an alcoholic swab. The blood sample was shifted to assigned plain bottle container, where it was allowed to clot at room temperature. The serum sample was separated from the blood sample through a centrifugation process at a speed of 5000 revolutions per minute (rpm) for 15 minutes and stored frozen in another bottle container until the time for analysis
Interventions
It is an amino acid which is synthesized by the demethylation of dietary methionine. It is a highly reactive, Sulfur-containing amino acid as a by-product of metabolism of essential amino acid specifically methionine. It was proved to be a strong risk factor causing many cardiovascular diseases, neurological disturbances and other health related issues
Eligibility Criteria
You may qualify if:
- Aged between 18 and 45 years.
- Enough ability to complete the blood sampling procedure.
- Residents lived in the community and can walk to hospital.
You may not qualify if:
- Participants outside the age range.
- History of malignancy, infection and other comorbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mubin Kiyani
Islamabad, Capital, 44000, Pakistan
Related Publications (8)
Karger AB, Steffen BT, Nomura SO, Guan W, Garg PK, Szklo M, Budoff MJ, Tsai MY. Association Between Homocysteine and Vascular Calcification Incidence, Prevalence, and Progression in the MESA Cohort. J Am Heart Assoc. 2020 Feb 4;9(3):e013934. doi: 10.1161/JAHA.119.013934. Epub 2020 Jan 30.
PMID: 32013703BACKGROUNDBalint B, Jepchumba VK, Gueant JL, Gueant-Rodriguez RM. Mechanisms of homocysteine-induced damage to the endothelial, medial and adventitial layers of the arterial wall. Biochimie. 2020 Jun;173:100-106. doi: 10.1016/j.biochi.2020.02.012. Epub 2020 Feb 24.
PMID: 32105811BACKGROUNDSharma GS, Bhattacharya R, Singh LR. Functional inhibition of redox regulated heme proteins: A novel mechanism towards oxidative stress induced by homocysteine. Redox Biol. 2021 Oct;46:102080. doi: 10.1016/j.redox.2021.102080. Epub 2021 Jul 23.
PMID: 34325357BACKGROUNDSamarron SL, Miller JW, Cheung AT, Chen PC, Lin X, Zwerdling T, Wun T, Green R. Homocysteine is associated with severity of microvasculopathy in sickle cell disease patients. Br J Haematol. 2020 Aug;190(3):450-457. doi: 10.1111/bjh.16618. Epub 2020 Apr 19.
PMID: 32307711BACKGROUNDPaganelli F, Mottola G, Fromonot J, Marlinge M, Deharo P, Guieu R, Ruf J. Hyperhomocysteinemia and Cardiovascular Disease: Is the Adenosinergic System the Missing Link? Int J Mol Sci. 2021 Feb 8;22(4):1690. doi: 10.3390/ijms22041690.
PMID: 33567540BACKGROUNDRong H, Huang L, Jin N, Hong J, Hu J, Wang S, Xie Y, Pu J. Elevated Homocysteine Levels Associated with Atrial Fibrillation and Recurrent Atrial Fibrillation. Int Heart J. 2020;61(4):705-712. doi: 10.1536/ihj.20-099.
PMID: 32727999BACKGROUNDWalli-Attaei M, Joseph P, Rosengren A, Chow CK, Rangarajan S, Lear SA, AlHabib KF, Davletov K, Dans A, Lanas F, Yeates K, Poirier P, Teo KK, Bahonar A, Camilo F, Chifamba J, Diaz R, Didkowska JA, Irazola V, Ismail R, Kaur M, Khatib R, Liu X, Manczuk M, Miranda JJ, Oguz A, Perez-Mayorga M, Szuba A, Tsolekile LP, Prasad Varma R, Yusufali A, Yusuf R, Wei L, Anand SS, Yusuf S. Variations between women and men in risk factors, treatments, cardiovascular disease incidence, and death in 27 high-income, middle-income, and low-income countries (PURE): a prospective cohort study. Lancet. 2020 Jul 11;396(10244):97-109. doi: 10.1016/S0140-6736(20)30543-2. Epub 2020 May 20.
PMID: 32445693BACKGROUNDDjurovic Z, Jovanovic V, Obrenovic R, Djurovic B, Soldatovic I, Vranic A, Jakovljevic V, Djuric D, Zivkovic V. The importance of the blood levels of homocysteine, folate and vitamin B12 in patients with primary malignant brain tumors. J BUON. 2020 Nov-Dec;25(6):2600-2607.
PMID: 33455102BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mubin Kiyani, PhD
Shifa Tameer-e-Millat University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 12, 2021
First Posted
August 18, 2021
Study Start
August 12, 2021
Primary Completion
September 9, 2021
Study Completion
September 12, 2021
Last Updated
September 10, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share