ST Segment Elevation Myocardial InfarctionSTresolutionNCT03895983
ST Segment Resolution After Primary Percutaneous Coronary Intervention.
An observational study of ST Segment Elevation Myocardial Infarction, run by Assiut University.
Trial summary
To compare the ST segment resolution after primary percutaneous coronary intervention (PPCI) with and without thrombus aspiration in patients with ST segment elevation myocardial infarction as ST segment resolution is the best indicator for the prediction of the outcome and MACE Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction
- What is being tested?
- Percutaneous primary coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Sep 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: 270 patients
Who may be able to join
- . patients with STEMI within 24 hours of chest pain.patients killip class 1 is included in this study
- xclusion Criteria:
- killip II-IV
- Previous myocardial infarction
- Patients with left bundle branch block
- Patients with advanced cancer disease
- Patients qith contraindications to anti-coagulation
- Patients with sensitivity to clopidogrel
Who cannot join
None listed.
About this study
Official title: SsST Segment Resolution After Primary Percutaneous Coronary Intervention. A Comparison Between Primary Percutaneous Coronary Intervention With and Without Thrombus Aspiration
To compare the ST segment resolution after primary percutaneous coronary intervention (PPCI) with and without thrombus aspiration in patients with ST segment elevation myocardial infarction as ST segment resolution is the best indicator for the prediction of the outcome and MACE
Read the detailed description
The idea of an occluding thrombus and its dissolution had been stated since the 1950s.1 Thrombus is present in the infarct-related artery in 88% of patients undergoing coronary artery angiography within the first 4 h of acute myocardial infarction (AMI).
The finding of ST segment elevation in a patient presenting with chest pain allows rapid identification of those who benefit from emergency reperfusion.
Primary percutaneous coronary intervention (PPCI) is now the preferred strategy for emergency reperfusion in patients presenting with ST elevation myocardial infarction (STEMI).
Thrombus aspiration (TA) might be an effective procedure for reducing distal embolization and improving microvascular perfusion in ST-segment elevation myocardial infarction (STEMI), especially in patients with high thrombus burden.
Despite the class III recommendation for routine Thrombus Aspiration use before balloon angioplasty or stenting. manual Thrombus Aspiration might still remain a useful strategy for the interventional cardiologist when treating selected patients with significant thrombus burden during PPCI.
Thrombus grading is classified as:
Grade 0: No angiographic characteristics of thrombus are present. Grade 1: Possible thrombus is present with a such characteristics as: Reduced contrast density, haziness, irregular lesion contour Or smooth convex meniscus at the site of total occlusion Suggestive but not diagnostic of the thrombus.
Grade 2: There is a definite thrombus with greatest dimension <1/2 the vessel diameter.
Grade 3: There is a definite thrombus but with greatest linear dimension>1/2 but <2 vessel dimension.
Grade 4: There is a definite thrombus but with greatest linear dimension >2 vessel dimension.
Grade 5: There is a total occlusion (unable to assess thrombus burden due to total vessel occlusion.
The analysis of ST-segment resolution on the electrocardiogram (ECG) consists of a simple tool, of easy use and low cost, able to document success of the epicardial reperfusion and tissue reperfusion after primary PCI.
The persistence of ST-segment elevation on the ECG, despite the restoration of a normal epicardial flow, signifies a poor prognosis; such persistence is known to be associated with larger infarct size and higher combined rate of severe cardiovascular adverse events.
- Being tested
- Percutaneous primary coronary intervention
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous primary coronary interventionProcedure or surgery
Percutaneous primary coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Thrombus aspiration group | Will include 135 patients who will have PPCI with thrombus aspiration Receives: Procedure: Percutaneous primary coronary intervention | |
| Standard PPCI group | Will include 135 patients who will have PPCI without thrombus aspiration Receives: Procedure: Percutaneous primary coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ST segment resolution
ST segment resolution in relation to the procedure used in primary percutaneous coronary intervention
Measured: Within 90 minutes after the procedure
Secondary outcomes (1)
MACE
the major adverse coronary events in correlation to ST segment resolution after primary percutaneous coronary intervention (recurrent angina, reinfarction, heart failure, major bleeding, disabling stroke or death) during the period of hospitalization.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Segment 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Ragab Abdel mageed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895983
- Sponsor's protocol ID
- AssiutU37
- Acronym
- STresolution
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SsST Segment Resolution After Primary Percutaneous Coronary Intervention. A Comparison Between Primary Percutaneous Coronary Intervention With and Without Thrombus Aspiration
- ClinicalTrials.gov ID
- NCT03895983
- Acronym / sponsor ID
- STresolution / AssiutU37
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 29 Mar 2019 (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.
To compare the ST segment resolution after primary percutaneous coronary intervention (PPCI) with and without thrombus aspiration in patients with ST segment elevation myocardial infarction as ST segment resolution is the best indicator for the prediction of the outcome and MACE
Detailed description
The idea of an occluding thrombus and its dissolution had been stated since the 1950s.1 Thrombus is present in the infarct-related artery in 88% of patients undergoing coronary artery angiography within the first 4 h of acute myocardial infarction (AMI).
The finding of ST segment elevation in a patient presenting with chest pain allows rapid identification of those who benefit from emergency reperfusion.
Primary percutaneous coronary intervention (PPCI) is now the preferred strategy for emergency reperfusion in patients presenting with ST elevation myocardial infarction (STEMI).
Thrombus aspiration (TA) might be an effective procedure for reducing distal embolization and improving microvascular perfusion in ST-segment elevation myocardial infarction (STEMI), especially in patients with high thrombus burden.
Despite the class III recommendation for routine Thrombus Aspiration use before balloon angioplasty or stenting. manual Thrombus Aspiration might still remain a useful strategy for the interventional cardiologist when treating selected patients with significant thrombus burden during PPCI.
Thrombus grading is classified as:
Grade 0: No angiographic characteristics of thrombus are present. Grade 1: Possible thrombus is present with a such characteristics as: Reduced contrast density, haziness, irregular lesion contour Or smooth convex meniscus at the site of total occlusion Suggestive but not diagnostic of the thrombus.
Grade 2: There is a definite thrombus with greatest dimension <1/2 the vessel diameter.
Grade 3: There is a definite thrombus but with greatest linear dimension>1/2 but <2 vessel dimension.
Grade 4: There is a definite thrombus but with greatest linear dimension >2 vessel dimension.
Grade 5: There is a total occlusion (unable to assess thrombus burden due to total vessel occlusion.
The analysis of ST-segment resolution on the electrocardiogram (ECG) consists of a simple tool, of easy use and low cost, able to document success of the epicardial reperfusion and tissue reperfusion after primary PCI.
The persistence of ST-segment elevation on the ECG, despite the restoration of a normal epicardial flow, signifies a poor prognosis; such persistence is known to be associated with larger infarct size and higher combined rate of severe cardiovascular adverse events.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombus aspiration group | – | Procedure: Percutaneous primary coronary interventionWill include 135 patients who will have PPCI with thrombus aspiration |
| Standard PPCI group | – | Procedure: Percutaneous primary coronary interventionWill include 135 patients who will have PPCI without thrombus aspiration |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 270 patients
Key inclusion criteria (8 listed)
- . patients with STEMI within 24 hours of chest pain.patients killip class 1 is included in this study
- killip II-IV
- Previous myocardial infarction
- Patients with left bundle branch block
- Patients with advanced cancer disease
Key exclusion criteria (0 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 |
|---|---|---|
| Percutaneous primary coronary interventionPercutaneous primary coronary intervention | Procedure or surgery | Standard PPCI group, Thrombus aspiration group |
Primary outcome
ST segment resolution
Time frame: Within 90 minutes after the procedure
ST segment resolution in relation to the procedure used in primary percutaneous coronary intervention
1 secondary outcome
MACE
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Segment Elevation Myocardial Infarction, 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 8 inclusion and 0 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 29 Mar 2019. 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?
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?
ST segment resolution (time frame: Within 90 minutes after the procedure). 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 29 Mar 2019.