Myocardial IschemiaST2NCT05686057
sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization
An observational study of Myocardial Ischemia and Heart Failure, run by Assiut University at 2 sites in Egypt.
Trial summary
The role of soluble circulating suppression of tumorigenicity 2 biomarker (sST2) in the ischemic heart disease patient is a debatable point. Therefore the aims of this study are to assess the plasma level of sST2 in ischemic heart disease patients versus non-ischemic ones, the acute changes in its level after… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Ischemia, Heart Failure, Coronary Intervention
- What is being tested?
- percutanous coronary angiography with stenting
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2022to Mar 2023
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All middle-old aged patients with IHD risk factors and acute or chronic coronary syndrome manifestations will undergo all routine investigations at baseline and after 24-48 hours of PCI and the levels of sST2 will be assessed for relations to acute changes in left ventricular EF by using 2-dimensional transthoracic echocardiography (2D-TTE) and the degree of ischemia by using Modified Gensini score. At the same time, the level of sST2 in control group with normal all routine diagnostic investigations will be assessed.
Who may be able to join
- Any patients aged 40 years or more and have the risk factors of ischemic heart disease (IHD) with coronary artery disease symptoms will be included.
- For control subjects should be aged ≥ 40 years old with IHD risk factors including DM and HTN and without any symptoms or signs of cardiac ischemia.
Who cannot join
- Any patient with heart failure (EF <50%), any patients with rhythm abnormalities including atrial fibrillation, obese patients, structural heart diseases, uncontrolled chronic diseases such as hypertension or diabetes mellitus, any pulmonary artery or parenchymal diseases up to respiratory failure, acute systemic infection or inflammation, and chronic/acute renal diseases.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
South Valley University Hospital
Qina, 83523
Areej AA Alkhateeb, Msc, +201023858689, areejalkhateeb@med.svu.edu.eg
Areej AA Tammam Alkhateeb, MD, PhD
- Recruiting
South Valley University
Qina
Alkhateeb, +201023858689, areejalkhateeb@med.svu.edu.eg
Areej AA Tammam Alkhateeb, MD, PhD
About this study
Official title: The Effect of Cardiac Ischemia and Percutaneous Coronary Intervention on the Changes of sST2 Level
The role of soluble circulating suppression of tumorigenicity 2 biomarker (sST2) in the ischemic heart disease patient is a debatable point. Therefore the aims of this study are to assess the plasma level of sST2 in ischemic heart disease patients versus non-ischemic ones, the acute changes in its level after percutaneous coronary intervention (PCI) and its relation to the severity of ischemia.
Read the detailed description
A comparison of ischemic patients and non-ischemic controls will be done. The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group. Then a study ischemic group will be divided into three subgroups; subgroup-1: single vessel disease, subgroup-2: two vessels disease and subgroup-3: multivessels disease. On admission, there will be a significant difference between the group of acute/chronic coronary syndrome cases and controls as regard sST2 plasma level or not. Moreover, the differences between the three ischemic subgroups at the baseline ST2 level will be assessed. The plasma sST2 level after PCI and the correlation between the acute change in pot-PCI sST2 level and the severity of ischemia by Modified Gensini Score (MGS) will be evaluated. The final question that will be answered by this study does the rapid impact of PCI on sST2 level will be mainly related to the severity of ischemia rather than left ventricular function or not.
- Conditions
- Myocardial Ischemia, Heart Failure, Coronary Intervention
- Being tested
- percutanous coronary angiography with stenting
- Keywords
- sST2 biomarker, Modified Gensini Score, Revascularization
- Medical subject headings
- Myocardial Ischemia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutanous coronary angiography with stentingDevice
Revascularization will be done by percutanous intervention after assessment of coronary stenosis by diagnostic coronary angiography under local anaesthesia with fluoroscopic guidance in acute/chronic coronary syndrome cases. The severity of stenosis will be done by modified gensini score from angiogram. An sST2 ELIZA test will be done after withdrawal of the cases' samples.
| Study group | Role | What they receive |
|---|---|---|
| single vessel diseased patients | sST2 level will be withdrawn at the baseline and after successful PCI Receives: Device: percutanous coronary angiography with stenting | |
| 2 vessels diseased patients | sST2 level will be withdrawn at the baseline and after successful PCI Receives: Device: percutanous coronary angiography with stenting | |
| multivessels diseased patients | sST2 level will be withdrawn at the baseline and after successful PCI Receives: Device: percutanous coronary angiography with stenting | |
| non-ischemic control patients | sST2 level will be withdrawn at the baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
sST2 biomarker level
baseline comparison between ischemic heart disease and non-ischemic heart disease-control groups
Measured: 24 hours before intervention
sST2 biomarker level
follow up of only ischemic heart disease groups of sST2 level changes after intervention
Measured: 48 hours post percutanous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Mar 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- South Valley University
- Responsible party
- Principal investigator, Areej Ahmad Abdullah Tammam Alkhateeb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686057
- Sponsor's protocol ID
- SVU2023
- Acronym
- ST2
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cardiac Ischemia and Percutaneous Coronary Intervention on the Changes of sST2 Level
- ClinicalTrials.gov ID
- NCT05686057
- Acronym / sponsor ID
- ST2 / SVU2023
- Conditions
- Myocardial Ischemia, Heart Failure, Coronary Intervention
- Keywords
- sST2 biomarker, Modified Gensini Score, Revascularization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- South Valley University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 17 Jan 2023 (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.
The role of soluble circulating suppression of tumorigenicity 2 biomarker (sST2) in the ischemic heart disease patient is a debatable point. Therefore the aims of this study are to assess the plasma level of sST2 in ischemic heart disease patients versus non-ischemic ones, the acute changes in its level after percutaneous coronary intervention (PCI) and its relation to the severity of ischemia.
Detailed description
A comparison of ischemic patients and non-ischemic controls will be done. The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group. Then a study ischemic group will be divided into three subgroups; subgroup-1: single vessel disease, subgroup-2: two vessels disease and subgroup-3: multivessels disease. On admission, there will be a significant difference between the group of acute/chronic coronary syndrome cases and controls as regard sST2 plasma level or not. Moreover, the differences between the three ischemic subgroups at the baseline ST2 level will be assessed. The plasma sST2 level after PCI and the correlation between the acute change in pot-PCI sST2 level and the severity of ischemia by Modified Gensini Score (MGS) will be evaluated. The final question that will be answered by this study does the rapid impact of PCI on sST2 level will be mainly related to the severity of ischemia rather than left ventricular function or not.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| single vessel diseased patients | – | Device: percutanous coronary angiography with stentingsST2 level will be withdrawn at the baseline and after successful PCI |
| 2 vessels diseased patients | – | Device: percutanous coronary angiography with stentingsST2 level will be withdrawn at the baseline and after successful PCI |
| multivessels diseased patients | – | Device: percutanous coronary angiography with stentingsST2 level will be withdrawn at the baseline and after successful PCI |
| non-ischemic control patients | – | –sST2 level will be withdrawn at the baseline |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All middle-old aged patients with IHD risk factors and acute or chronic coronary syndrome manifestations will undergo all routine investigations at baseline and after 24-48 hours of PCI and the levels of sST2 will be assessed for relations to acute changes in left ventricular EF by using 2-dimensional transthoracic echocardiography (2D-TTE) and the degree of ischemia by using Modified Gensini score. At the same time, the level of sST2 in control group with normal all routine diagnostic investigations will be assessed.
Key inclusion criteria (2 listed)
- Any patients aged 40 years or more and have the risk factors of ischemic heart disease (IHD) with coronary artery disease symptoms will be included.
- For control subjects should be aged ≥ 40 years old with IHD risk factors including DM and HTN and without any symptoms or signs of cardiac ischemia.
Key exclusion criteria (1 listed)
- Any patient with heart failure (EF <50%), any patients with rhythm abnormalities including atrial fibrillation, obese patients, structural heart diseases, uncontrolled chronic diseases such as hypertension or diabetes mellitus, any pulmonary artery or parenchymal diseases up to respiratory failure, acute systemic infection or inflammation, and chronic/acute renal diseases.
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 |
|---|---|---|
| percutanous coronary angiography with stentingRevascularization will be done by percutanous intervention after assessment of coronary stenosis by diagnostic coronary angiography under local anaesthesia with fluoroscopic guidance in acute/chronic coronary syndrome cases. The severity of stenosis will be done by modified gensini score from angiogram. An sST2 ELIZA test will be done after withdrawal of the cases' samples. | Device | 2 vessels diseased patients, multivessels diseased patients, single vessel diseased patients |
Primary outcome
sST2 biomarker level
Time frame: 24 hours before intervention
baseline comparison between ischemic heart disease and non-ischemic heart disease-control groups
sST2 biomarker level
Time frame: 48 hours post percutanous coronary intervention
follow up of only ischemic heart disease groups of sST2 level changes after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia and Heart Failure, run by Assiut University at 2 sites 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 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 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alkhateeb (+201023858689, areejalkhateeb@med.svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sST2 biomarker level (time frame: 24 hours before intervention). 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?
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 17 Jan 2023.