NCT05011032

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

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Completed
Same day until next milestone

Study Start

First participant enrolled

August 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

28 days

First QC Date

August 12, 2021

Last Update Submit

September 2, 2021

Conditions

Keywords

Blood SedimentationCardiovascular DiseasesDiabetes MellitusHomocysteineLeukocytesCholesterol

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

OTHER

The 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

Diagnostic Test: Homocysteine

Non-diabetic cardiac

EXPERIMENTAL

The 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

Diagnostic Test: Homocysteine

Diabetic cardiac

EXPERIMENTAL

The 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

Diagnostic Test: Homocysteine

Interventions

HomocysteineDIAGNOSTIC_TEST

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

Control GroupDiabetic cardiacNon-diabetic cardiac

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 32013703BACKGROUND
  • Balint 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: 32105811BACKGROUND
  • Sharma 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: 34325357BACKGROUND
  • Samarron 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: 32307711BACKGROUND
  • Paganelli 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: 33567540BACKGROUND
  • Rong 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: 32727999BACKGROUND
  • Walli-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: 32445693BACKGROUND
  • Djurovic 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

Metabolic DiseasesCardiovascular DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • Mubin Kiyani, PhD

    Shifa Tameer-e-Millat University

    PRINCIPAL INVESTIGATOR
0

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

Locations