Serum CopperNCT07076758
Correlation Between Serum Copper and Cardiac Enzymes in Acute Myocardial Infarction
An observational study of Serum Copper and Cardiac Enzymes, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to investigate the correlation between serum copper levels and cardiac enzymes in patients with acute myocardial infarction (AMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serum Copper, Cardiac Enzymes, Acute Myocardial Infarction
- What is being tested?
- Transthoracic echocardiography
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 8 Jul 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This case-control study will be conducted at Sohag University Hospitals after approval from the institutional ethical committee.
Who may be able to join
- Age ≥18 years old.
- Both sexes.
- Patients with acute myocardial infarction (AMI). AMI are defined as patients complaining of typical continuous chest pain for more than 30 min: ST-segment elevation of more than 0.1 mV in two or more successive leads or ST-segment depression of more than 0.1 mV in two or more successive leads monitored by a standard 12-lead ECG and rise of either creatine kinase (CK) or MB fraction of creatine kinase (CKMB) to greater than twice the normal level or elevation of troponin I [cardiac troponin T (cTnT)] more than or equal to 0.1 ng/ml
Who cannot join
- Patients with insufficient clinical information.
- Passed time MI (if patients presented with symptoms that lasted >24 h).
- Cardiogenic shock.
- Chronic kidney disease.
- Chronic liver cell failure.
- Significant valvular heart disease.
Show all 13Show fewer
- Hematological disease.
- Malignancy.
- Severe liver or renal disease.
- Systemic inflammatory disease.
- Active infection.
- Autoimmune disease.
- Patients on steroids whatever the cause is.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the correlation between serum copper levels and cardiac enzymes in patients with acute myocardial infarction (AMI).
Read the detailed description
Acute myocardial infarction (AMI) is one of the most serious types of coronary artery disease (CAD). In CAD, coronary blood flow is drastically reduced or interrupted, causing severe myocardial ischemia or necrosis.
Cardiac troponin I (TNI), creatine kinase (CK), and creatine kinase MB (CK-MB) are the most commonly used biomarkers for AMI clinical diagnosis. Among them, cardiac troponin is a highly specific biomarker for the diagnosis of AMI. However, the sensitivity is not good in the first few AMI hours, and false-positive values may occur in severe heart failure, arrhythmia, and myocarditis.
Copper is vital in multiple enzymes necessary for antioxidant protection, such as Superoxide dismutases (SOD) and ceruloplasmin. SOD is an enzyme that changes superoxide radicals into hydrogen peroxide, whereas ceruloplasmin is an antioxidant protein that aids in eliminating free radicals.
- Conditions
- Serum Copper, Cardiac Enzymes, Acute Myocardial Infarction
- Being tested
- Transthoracic echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyOther
Transthoracic echocardiography will be done for all patients during their cardiac care unit stay including two-dimensional and color Doppler echocardiography studies. It will be performed in the left lateral position using the parasternal and apical transducer positions. All studies will be technically adequate for scoring endocardial regional wall motion. The following views will be obtained: long-axis parasternal, short-axis parasternal, apical four chamber, apical two-chamber and apical five-chamber views. All the measurements taken will be according to the criteria of the American Society of Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients with acute myocardial infarction. Receives: Other: Transthoracic echocardiography | |
| Group II | Healthy control individuals as a control group. Receives: Other: Transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum copper level
Serum copper level will be recorded.
Measured: Immediately after echocardiography (Up to 1 hour)
Secondary outcomes (4)
Correlation between copper zinc and cardiac enzyme
Correlation between copper zinc and cardiac enzyme will be done.
Measured: Immediately after echocardiography (Up to 1 hour)
Creatine kinase
Creatine kinase level will be recorded.
Measured: Immediately after echocardiography (Up to 1 hour)
MB fraction of creatine kinase
MB fraction of creatine kinase will be recorded.
Measured: Immediately after echocardiography (Up to 1 hour)
Cardiac troponin T
Cardiac troponin T will be recorded.
Measured: Immediately after echocardiography (Up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2025
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum CopperStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remon Saleh Adly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076758
- Sponsor's protocol ID
- Soh-Med-25-5-7PD
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Serum Copper and Cardiac Enzymes in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07076758
- Acronym / sponsor ID
- Soh-Med-25-5-7PD
- Conditions
- Serum Copper, Cardiac Enzymes, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 22 Jul 2025 (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 investigate the correlation between serum copper levels and cardiac enzymes in patients with acute myocardial infarction (AMI).
Detailed description
Acute myocardial infarction (AMI) is one of the most serious types of coronary artery disease (CAD). In CAD, coronary blood flow is drastically reduced or interrupted, causing severe myocardial ischemia or necrosis.
Cardiac troponin I (TNI), creatine kinase (CK), and creatine kinase MB (CK-MB) are the most commonly used biomarkers for AMI clinical diagnosis. Among them, cardiac troponin is a highly specific biomarker for the diagnosis of AMI. However, the sensitivity is not good in the first few AMI hours, and false-positive values may occur in severe heart failure, arrhythmia, and myocarditis.
Copper is vital in multiple enzymes necessary for antioxidant protection, such as Superoxide dismutases (SOD) and ceruloplasmin. SOD is an enzyme that changes superoxide radicals into hydrogen peroxide, whereas ceruloplasmin is an antioxidant protein that aids in eliminating free radicals.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: Transthoracic echocardiographyPatients with acute myocardial infarction. |
| Group II | – | Other: Transthoracic echocardiographyHealthy control individuals as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This case-control study will be conducted at Sohag University Hospitals after approval from the institutional ethical committee.
Key inclusion criteria (3 listed)
- Age ≥18 years old.
- Both sexes.
- Patients with acute myocardial infarction (AMI). AMI are defined as patients complaining of typical continuous chest pain for more than 30 min: ST-segment elevation of more than 0.1 mV in two or more successive leads or ST-segment depression of more than 0.1 mV in two or more successive leads monitored by a standard 12-lead ECG and rise of either creatine kinase (CK) or MB fraction of creatine kinase (CKMB) to greater than twice the normal level or elevation of troponin I [cardiac troponin T (cTnT)] more than or equal to 0.1 ng/ml
Key exclusion criteria (13 listed)
- Patients with insufficient clinical information.
- Passed time MI (if patients presented with symptoms that lasted >24 h).
- Cardiogenic shock.
- Chronic kidney disease.
- Chronic liver cell failure.
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 |
|---|---|---|
| Transthoracic echocardiographyTransthoracic echocardiography will be done for all patients during their cardiac care unit stay including two-dimensional and color Doppler echocardiography studies. It will be performed in the left lateral position using the parasternal and apical transducer positions. All studies will be technically adequate for scoring endocardial regional wall motion. The following views will be obtained: long-axis parasternal, short-axis parasternal, apical four chamber, apical two-chamber and apical five-chamber views. All the measurements taken will be according to the criteria of the American Society of Echocardiography | Other | Group I, Group II |
Primary outcome
Serum copper level
Time frame: Immediately after echocardiography (Up to 1 hour)
Serum copper level will be recorded.
4 secondary outcomes
Correlation between copper zinc and cardiac enzyme
Time frame: Immediately after echocardiography (Up to 1 hour)
Creatine kinase
Time frame: Immediately after echocardiography (Up to 1 hour)
MB fraction of creatine kinase
Time frame: Immediately after echocardiography (Up to 1 hour)
Cardiac troponin T
Time frame: Immediately after echocardiography (Up to 1 hour)
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 22 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Serum Copper and Cardiac Enzymes, 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 3 inclusion and 13 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 22 Jul 2025. 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?
Serum copper level (time frame: Immediately after echocardiography (Up to 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2025.