Effects of Homocysteine in Myocardial Infarction Patients in a Tertiary Care Hospital of Pakistan

Homocystine; Metabolic Disorder Clinical Trial

Official title:

Effects of Homocysteine in Myocardial Infarction Patients in a Tertiary Care Hospital of Twin Cities of Pakistan

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05011032
• Other study ID #: Mubin 0011
• Status: Withdrawn
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: September 12, 2021

Study information

• Verified date: September 2021
• Source: Aqua Medical Services (Pvt) Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Excess of low density lipoproteins, high blood pressure, obesity, excess of blood sugar levels, smoking and sedentary life style are the known modifiable risk factors causing cardiovascular disease specifically Coronary disease. There can be some other substances which can additionally affect the human cardiac physiology as well i.e. high levels of Homocysteine molecule in the blood. The adverse effects of this component on multiple system of human body are evidenced in the literature since 1962 involving Nervous system, brain, Renal system, Liver functioning, Venus system and endothelial system and are still under debate. This biochemical agent has a strong relevance with the physiology of cardiovascular system and causes disturbance in the arterial supply of the heart in young population. Homocysteine has been under a lot of discussion 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. Homocysteine has a strong relation with the diseases involving hardening of arteries and blood clots related vascular problems.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 12, 2021
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 45 years.
• Enough ability to complete the blood sampling procedure.
• Residents lived in the community and can walk to hospital.

Exclusion Criteria:

• Participants outside the age range.
• History of malignancy, infection and other comorbidities

Related Conditions & MeSH terms

• Homocystine; Metabolic Disorder
• Infarction
• Metabolic Diseases
• Myocardial Infarction

Intervention

Diagnostic Test:
• Homocysteine
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

Locations

Country	Name	City	State
Pakistan	Mubin Kiyani	Islamabad	Capital

Sponsors (1)

Lead Sponsor	Collaborator
Aqua Medical Services (Pvt) Ltd

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Balint B, Jepchumba VK, Guéant JL, Guéant-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. Review. — View Citation

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. — View Citation

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. — View Citation

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). pii: 1690. doi: 10.3390/ijms22041690. Review. — View Citation

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. — View Citation

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. — View Citation

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 Jul 23;46:102080. doi: 10.1016/j.redox.2021.102080. [Epub ahead of print] — View Citation

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. Erratum in: Lancet. 2020 May 29;:. Erratum in: Lancet. 2020 Aug 1;396(10247):312. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homocysteine	It a marker of cardiovascular diseases.	4th weeks
Primary	Erythrocyte sedimentation rate (ESR)	It a marker of cardiovascular diseases.	4th weeks