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

September 2, 2021 updated by: Mir Arif Hussain, Aqua Medical Services (Pvt) Ltd

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Capital
      • Islamabad, Capital, Pakistan, 44000
        • Mubin Kiyani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homocysteine
Time Frame: 4th weeks
It a marker of cardiovascular diseases.
4th weeks
Erythrocyte sedimentation rate (ESR)
Time Frame: 4th weeks
It a marker of cardiovascular diseases.
4th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aqua Medical Services (Pvt) Ltd

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2021

Primary Completion (Anticipated)

September 9, 2021

Study Completion (Anticipated)

September 12, 2021

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mubin 0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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