Homocystine; Metabolic DisorderNCT05011032
Effects of Homocysteine in Myocardial Infarction Patients in a Tertiary Care Hospital of Pakistan
A study testing Homocysteine in people with Homocystine; Metabolic Disorder, run by Aqua Medical Services (Pvt) Ltd at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Homocystine; Metabolic Disorder
- What is being tested?
- Homocysteine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Aug 2021to 12 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 45 years.
- Enough ability to complete the blood sampling procedure.
- Residents lived in the community and can walk to hospital.
Who cannot join
- Participants outside the age range.
- History of malignancy, infection and other comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Homocystine; Metabolic Disorder
- Being tested
- Homocysteine
- Keywords
- Blood Sedimentation, Cardiovascular Diseases, Diabetes Mellitus, Homocysteine, Leukocytes, Cholesterol
- Medical subject headings
- Metabolic Diseases, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Homocysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homocysteine
It a marker of cardiovascular diseases.
Measured: 4th weeks
Erythrocyte sedimentation rate (ESR)
It a marker of cardiovascular diseases.
Measured: 4th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start12 Aug 2021
- Primary completion9 Sep 2021 (estimated)
- Study completion12 Sep 2021 (estimated)
Why it stopped: Ethical approval was not done. Hence the funding was withhold.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Homocystine; Metabolic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aqua Medical Services (Pvt) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Mir Arif Hussain, Aqua Medical Services (Pvt) Ltd
- Investigators
- Mubin Kiyani, PhD, Principal investigator, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011032
- Sponsor's protocol ID
- Mubin 0011
- Status last verified
- Sep 2021
- First submitted
- 12 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32013703Balint 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.
PubMed 32105811Sharma 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.
PubMed 34325357Samarron 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.
PubMed 32307711Paganelli 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.
PubMed 33567540Rong 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.
PubMed 32727999Walli-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.
PubMed 32445693Djurovic 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.
PubMed 33455102
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Homocysteine in Myocardial Infarction Patients in a Tertiary Care Hospital of Twin Cities of Pakistan
- ClinicalTrials.gov ID
- NCT05011032
- Acronym / sponsor ID
- Mubin 0011
- Conditions
- Homocystine; Metabolic Disorder
- Keywords
- Blood Sedimentation, Cardiovascular Diseases, Diabetes Mellitus, Homocysteine, Leukocytes, Cholesterol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ethical approval was not done. Hence the funding was withhold.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aqua Medical Services (Pvt) LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 9 Sep 2021 (estimated)
- Study completion
- 12 Sep 2021 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Diagnostic Test: HomocysteineThe 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 | Experimental | Diagnostic Test: HomocysteineThe 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 | Experimental | Diagnostic Test: HomocysteineThe 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18 and 45 years.
- Enough ability to complete the blood sampling procedure.
- Residents lived in the community and can walk to hospital.
Key exclusion criteria (2 listed)
- Participants outside the age range.
- History of malignancy, infection and other comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HomocysteineIt 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 | Diagnostic test | Control Group, Diabetic cardiac, Non-diabetic cardiac |
Primary outcome
Homocysteine
Time frame: 4th weeks
It a marker of cardiovascular diseases.
Erythrocyte sedimentation rate (ESR)
Time frame: 4th weeks
It a marker of cardiovascular diseases.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Background: PubMed 32013703Karger 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.
- Background: PubMed 32105811Balint 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.
- Background: PubMed 34325357Sharma 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.
- Background: PubMed 32307711Samarron 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.
- Background: PubMed 33567540Paganelli 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.
- Background: PubMed 32727999Rong 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.
- Background: PubMed 32445693Walli-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.
- Background: PubMed 33455102Djurovic 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mubin Kiyani, PhD principal investigator
Shifa Tameer-e-Millat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homocysteine in people with Homocystine; Metabolic Disorder, run by Aqua Medical Services (Pvt) Ltd at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homocysteine (time frame: 4th weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011032, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.