Acute Coronary SyndromeNCT05125419
Homocysteine in Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to determine the relation between high homocysteine levels and increased incidence of acute coronary syndrome in young patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Homocysteine level
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2021to 1 Jul 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients presented with acute coronary syndrome admitted to coronary care unit of Sohag University hospital according to inclusion and exclusion criteria
Who may be able to join
- - The patients who presented in the hospital with chest pain consistent with acute coronary syndrome with any of the following features:
- Electrocardiogram (ECG) changes:
- ST elevation
- ST depression
- T wave inversion
- recent left bundle branch block
- Troponin T elevation (Norma value < 0.06)
- 2- Age: -Between 18- 40 years (Group A) - Age > 40 years (Group B)
Who cannot join
- Chest pain not consistent with acute coronary syndrome
- Chronic kidney disease (CKD)
- Rheumatic heart disease (RHD)
- Congenital heart disease
- Anemia
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Homocysteine Level in the Setting of Acute Coronary Syndrome in Young Adult Patients
This study aims to determine the relation between high homocysteine levels and increased incidence of acute coronary syndrome in young patients
Read the detailed description
Cross sectional study to:
assess homocysteine level in young adult patients presenting with acute coronary syndrome
- Conditions
- Acute Coronary Syndrome
- Being tested
- Homocysteine level
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homocysteine levelDiagnostic test
Also called HCY
diagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary care unit admission with acute coronary syndrome
Acute coronary syndrome hospitalization and cardiovascular deathes and estimated hazard ratios (HR) by use of multivariable Cox regression models
Measured: From date of randomization up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start30 Nov 2021
- Primary completion30 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelnasser Labib, Sohag University
- Investigators
- Mohammed E Amin, Lecturer, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125419
- Sponsor's protocol ID
- Homocysteine level
- Status last verified
- Jul 2023
- First submitted
- 6 Nov 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu J, Quan J, Li Y, Wu Y, Yang L. Blood homocysteine levels could predict major adverse cardiac events in patients with acute coronary syndrome: A STROBE-compliant observational study. Medicine (Baltimore). 2018 Oct;97(40):e12626. doi: 10.1097/MD.0000000000012626.
PubMed 30290636
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Homocysteine Level in the Setting of Acute Coronary Syndrome in Young Adult Patients
- ClinicalTrials.gov ID
- NCT05125419
- Acronym / sponsor ID
- Homocysteine level
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 18 Nov 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.
This study aims to determine the relation between high homocysteine levels and increased incidence of acute coronary syndrome in young patients
Detailed description
Cross sectional study to:
assess homocysteine level in young adult patients presenting with acute coronary syndrome
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presented with acute coronary syndrome admitted to coronary care unit of Sohag University hospital according to inclusion and exclusion criteria
Key inclusion criteria (8 listed)
- - The patients who presented in the hospital with chest pain consistent with acute coronary syndrome with any of the following features:
- 2- Age: -Between 18- 40 years (Group A) - Age > 40 years (Group B)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Homocysteine levelAlso: HCYdiagnostic test | Diagnostic test | – |
Primary outcome
Coronary care unit admission with acute coronary syndrome
Time frame: From date of randomization up to 1 month
Acute coronary syndrome hospitalization and cardiovascular deathes and estimated hazard ratios (HR) by use of multivariable Cox regression models
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 30290636Liu J, Quan J, Li Y, Wu Y, Yang L. Blood homocysteine levels could predict major adverse cardiac events in patients with acute coronary syndrome: A STROBE-compliant observational study. Medicine (Baltimore). 2018 Oct;97(40):e12626. doi: 10.1097/MD.0000000000012626.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed E Amin, Lecturer study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Sohag University at 1 site in Egypt.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 6 Jul 2023. 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coronary care unit admission with acute coronary syndrome (time frame: From date of randomization up to 1 month). 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 NCT05125419, which also lists 1 linked publication.
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 6 Jul 2023.