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

Sponsor
Aqua Medical Services (Pvt) Ltd (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT05011032
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Homocysteine
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Effects of Homocysteine in Myocardial Infarction Patients in a Tertiary Care Hospital of Twin Cities of Pakistan
Actual Study Start Date :
Aug 12, 2021
Anticipated Primary Completion Date :
Sep 9, 2021
Anticipated Study Completion Date :
Sep 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Control Group

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
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

Experimental: Non-diabetic cardiac

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
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

Experimental: Diabetic cardiac

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
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

Outcome Measures

Primary Outcome Measures

  1. Homocysteine [4th weeks]

    It a marker of cardiovascular diseases.

  2. Erythrocyte sedimentation rate (ESR) [4th weeks]

    It a marker of cardiovascular diseases.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mubin Kiyani Islamabad Capital Pakistan 44000

Sponsors and Collaborators

  • Aqua Medical Services (Pvt) Ltd

Investigators

  • Principal Investigator: Mubin Kiyani, PhD, Shifa Tameer-e-Millat University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mir Arif Hussain, Director, Aqua Medical Services (Pvt) Ltd
ClinicalTrials.gov Identifier:
NCT05011032
Other Study ID Numbers:
  • Mubin 0011
First Posted:
Aug 18, 2021
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mir Arif Hussain, Director, Aqua Medical Services (Pvt) Ltd
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2021