ST Elevation Myocardial InfarctionNCT05246215
Diagnostic Values of Galectin-3, Soluble ST2 and BNP in Predicting the Clinical Outcome of ST-Segment Elevation Myocardial Infarction Patients
An observational study of ST Elevation Myocardial Infarction and HF - Heart Failure, run by Assiut University.
Trial summary
An acute ST-elevation myocardial infarction occurs due to occlusion of one or more coronary arteries, causing transmural myocardial ischemia which in turn results in myocardial injury or necrosis. Acute myocardial infarction (AMI) may lead to the development of heart failure (HF). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ST Elevation Myocardial Infarction, HF - Heart Failure, Stable Angina
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Mar 2026
- 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: Assuit University Hospital.
Who may be able to join
- Age ≥ 18 years.
- Hospital admission due to first-time STEMI treated with pPCI.
Who cannot join
- History of previous acute coronary syndrome, Previously diagnosed HF or asymptomatic LV dysfunction with LVEF <50% or previously diagnosed significant valvular disease or any other previously diagnosed structural heart disease Severe renal dysfunction, Severe liver disease, Chronic inflammatory disease, Current neoplastic disease
Trial locations and contacts
No sites are listed yet.
About this study
An acute ST-elevation myocardial infarction occurs due to occlusion of one or more coronary arteries, causing transmural myocardial ischemia which in turn results in myocardial injury or necrosis. Acute myocardial infarction (AMI) may lead to the development of heart failure (HF). Accessible diagnostic tools commonly used in HF such as natriuretic peptides and (NYHA) classification reflect already overt clinical HF. Troponin and creatine kinase reflect myocardial damage, but their usefulness in predicting long-term LVR is limited. Recent guidelines on HF management stressed that HF onset may be delayed or prevented through certain Interventions, such as pharmacotherapy ,post infarction rehabilitation, or modification of HF risk factors. Therefore, it is important to identify potential markers, which would be more informative of HF preclinical stages to recognize patients with an increased risk of HF onset, and to start treatment in advance (1) Gal-3 participates in inflammation and pro fibrotic pathways, while sST2 is a biomarker of inflammation, cardiac mechanical strain, and tissue fibrosis, both of which may predict LVR (2).
sST is a biomarker of inflammation, cardiac mechanical strain, and tissue fibrosis(3).
B_type natriuretic peptide (BNP) is elevated in acute myocardial infarction and is a quantitative biochemical marker related to the extent of infarction and left ventricular systolic dysfunction(4).
- Keywords
- Galectin-3
- Medical subject headings
- ST Elevation Myocardial Infarction, Heart Failure, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STEMI group. | 60 participants of patients with STEMI treated with primary percutaneous coronary intervention (pPCI). | |
| healthy group. | 15 participants of healthy people as a case control. | |
| Stable angina group. | 15 participants of patients stable angina |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate the association of Gal-3, sST2 and BNP concentrations and the development of clinically overt HF in patients after ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Khalifa Mohamed Abdelzaher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246215
- Sponsor's protocol ID
- DV_Gal_3,sST2
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Values of Galectin-3, Soluble ST2 and BNP in Predicting the Clinical Outcome of ST-Segment Elevation Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT05246215
- Acronym / sponsor ID
- DV_Gal_3,sST2
- Keywords
- Galectin-3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 18 Feb 2022 (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.
An acute ST-elevation myocardial infarction occurs due to occlusion of one or more coronary arteries, causing transmural myocardial ischemia which in turn results in myocardial injury or necrosis. Acute myocardial infarction (AMI) may lead to the development of heart failure (HF). Accessible diagnostic tools commonly used in HF such as natriuretic peptides and (NYHA) classification reflect already overt clinical HF. Troponin and creatine kinase reflect myocardial damage, but their usefulness in predicting long-term LVR is limited. Recent guidelines on HF management stressed that HF onset may be delayed or prevented through certain Interventions, such as pharmacotherapy ,post infarction rehabilitation, or modification of HF risk factors. Therefore, it is important to identify potential markers, which would be more informative of HF preclinical stages to recognize patients with an increased risk of HF onset, and to start treatment in advance (1) Gal-3 participates in inflammation and pro fibrotic pathways, while sST2 is a biomarker of inflammation, cardiac mechanical strain, and tissue fibrosis, both of which may predict LVR (2).
sST is a biomarker of inflammation, cardiac mechanical strain, and tissue fibrosis(3).
B_type natriuretic peptide (BNP) is elevated in acute myocardial infarction and is a quantitative biochemical marker related to the extent of infarction and left ventricular systolic dysfunction(4).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STEMI group. | – | –60 participants of patients with STEMI treated with primary percutaneous coronary intervention (pPCI). |
| healthy group. | – | –15 participants of healthy people as a case control. |
| Stable angina group. | – | –15 participants of patients stable angina |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Assuit University Hospital.
Key inclusion criteria (2 listed)
- Age ≥ 18 years.
- Hospital admission due to first-time STEMI treated with pPCI.
Key exclusion criteria (1 listed)
- History of previous acute coronary syndrome, Previously diagnosed HF or asymptomatic LV dysfunction with LVEF <50% or previously diagnosed significant valvular disease or any other previously diagnosed structural heart disease Severe renal dysfunction, Severe liver disease, Chronic inflammatory disease, Current neoplastic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
investigate the association of Gal-3, sST2 and BNP concentrations and the development of clinically overt HF in patients after ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction and HF - Heart Failure, run by Assiut University.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Khalifa Abdelzaher (+201158166015, aya.khalifa150@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate the association of Gal-3, sST2 and BNP concentrations and the development of clinically overt HF in patients after ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (time frame: 7 months). 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 18 Feb 2022.