In-hospital Clinical Outcome of Deferred Stenting Versus Immediate Stenting in the Management of Acute STEMI Presenting With High Thrombus Burden.
Primary Purpose
Coronary Thrombosis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Primary Percutaneous coronary angiography
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Thrombosis
Eligibility Criteria
Inclusion Criteria: TIMI 2-3 flow in the infarct related artery (IRA) with high thrombus burden at initial angiography. TIMI 2-3 in the IRA with high thrombus burden after MIMI. Exclusion Criteria: TIMI 0-1 flow in the IRA after MIMI. TIMI 2-3 in the IRA with low thrombus burden. Contraindication or hypersensitivity to Tirofiban High bleeding risk calculated using the CRUSADE score >50.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI
Non-deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI
Arm Description
Outcomes
Primary Outcome Measures
Effectiveness of the method used in terms of TIMI flow
By TIMI III flow finding
Effectiveness of the method used in regards to ECG.
ECG: ST segment resolution immediately after PCI and 90 minutes after PCI
Effectiveness of the method used in regards to development of heart failure.
Development of acute heart failure after PCI during hospital admission.
Effectiveness of the method used in regards to mortality.
Death during hospital stay post-PCI.
Safety of the method used in regards to bleeding.
Bleeding events will be noted and classified according to BARC (Bleeding Academic Research Consortium) bleeding score during hospital stay post-PCI
Safety of the method used in regard to development of arrhythmia.
Development of arrhythmia post-PCI will be noted and the type of arrhythmia will be identified.
Secondary Outcome Measures
Follow up post-PCI by trans-thoracic Echo
To estimate the ejection fraction on discharge.
Follow up post-PCI in regards to MACE (Major adverse cardiac events)
The development of MACE: Death, myocardial infarction, hospitalization due to heart failure, recurrent PCI or CABG.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05647018
Brief Title
In-hospital Clinical Outcome of Deferred Stenting Versus Immediate Stenting in the Management of Acute STEMI Presenting With High Thrombus Burden.
Official Title
In-hospital Clinical Outcome of Deferred Stenting Versus Immediate Stenting in the Management of Acute STEMI Presenting With High Thrombus Burden: A Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To compare the in hospital clinical outcomes in terms of efficacy and safety of deferred stenting versus non-deferred stenting in STEMI patients with high thrombus burden undergoing primary percutaneous intervention.
Detailed Description
Angiographically, intracoronary thrombus is defined as the presence of a filling defect with reduced contrast density or haziness. Angiographic evidence of thrombus can be seen in 91.6% of patients who present with STEMI(1). Large intracoronary thrombus has an incidence of 16.4% of patients with acute coronary syndrome (ACS).
Thrombus encountered in the setting of ACS has been correlated with acute complications during percutaneous coronary interventions including: 3 times higher MACE - ischemic complications, lower procedural success, higher distal embolization leading to slow/no flow, high mortality, ST elevation and longer hospital stays.
High thrombus burden can be defined using Yip's criteria:
Large infarct-related artery (visually estimated reference vessel diameter ≥ 4 mm)
Angiographic thrombus with the greatest linear dimension > 3 times the reference vessel diameter;
"Cutoff pattern" (lesion morphology with an abrupt cutoff without taper before the occlusion);
Accumulated thrombus (> 5 mm of linear dimension) proximal to the occlusion;
Floating thrombus proximal to the occlusion;
Persistent dye stasis distal to the obstruction. IF more than two criteria indicate the presence of very high thrombus burden.
PCI Strategies introduced in HIGH thrombus BURDEN include incorporation of both pharmacological and mechanical thrombus removal.
Immediate stenting of the culprit coronary artery may lead to high chances of the slow-flow/no-reflow phenomenon that leads to periprocedural MI and adverse cardiovascular events. Current studies show that routine deferred stenting has not been found beneficial except when careful patient selection is done where deferral may reduce the final infarct size.
Glycoprotein IIa/IIIb inhibitors have been used in such cases. Current guidelines recommend GPIIa/IIb as bailout therapy following PCI when massive thrombus is found: Class IIa. (6) The rationale in using intracoronary GPIIa/IIIb is that it can be more effective, faster and safer in terms of bleeding.
Deferred stenting is a method of dealing with thigh thrombus burden in STEMI patients. This means to wait 24-48 hour and delay stenting. During this time gap, patient receives intravenous tirofiban. This may be beneficial as the thrombus burden will reduce, minimizing the occurrence of the slow-flow/no-reflow phenomenon.
During coronary angiography the epicardial perfusion can be demonstrated using the TIMI grade flow where:
TIMI 0 flow (no perfusion) complete blockage - absence of any antegrade flow (forward flow) beyond a coronary occlusion.
TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.
TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.
TIMI 3 is normal flow which fills the distal coronary bed completely. (7) During Primary PCI, If TIMI 0-1 flow is encountered a technique called minimally invasive mechanical intervention (MIMI) can be employed to restore flow. This MIMI entails the use of a guidewire, an undersized balloon or thrombus aspiration to establish distal coronary flow.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI
Arm Type
Active Comparator
Arm Title
Non-deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Primary Percutaneous coronary angiography
Other Intervention Name(s)
Minimally invasive mechanical intervention
Intervention Description
Percutaneous coronary intervention (PCI) refers to a family of minimally invasive procedures used to open clogged coronary arteries in patients presenting with myocardial infarction, through which installment of stents or intracoronary injection of drugs can take place.
Primary Outcome Measure Information:
Title
Effectiveness of the method used in terms of TIMI flow
Description
By TIMI III flow finding
Time Frame
During in hospital stay up to 36 hours
Title
Effectiveness of the method used in regards to ECG.
Description
ECG: ST segment resolution immediately after PCI and 90 minutes after PCI
Time Frame
During in hospital stay up to 36 hours
Title
Effectiveness of the method used in regards to development of heart failure.
Description
Development of acute heart failure after PCI during hospital admission.
Time Frame
During in hospital stay up to 36 hours
Title
Effectiveness of the method used in regards to mortality.
Description
Death during hospital stay post-PCI.
Time Frame
During in hospital stay up to 36 hours
Title
Safety of the method used in regards to bleeding.
Description
Bleeding events will be noted and classified according to BARC (Bleeding Academic Research Consortium) bleeding score during hospital stay post-PCI
Time Frame
During in hospital stay up to 36 hours
Title
Safety of the method used in regard to development of arrhythmia.
Description
Development of arrhythmia post-PCI will be noted and the type of arrhythmia will be identified.
Time Frame
During in hospital stay up to 36 hours
Secondary Outcome Measure Information:
Title
Follow up post-PCI by trans-thoracic Echo
Description
To estimate the ejection fraction on discharge.
Time Frame
During in hospital stay up to 36 hours
Title
Follow up post-PCI in regards to MACE (Major adverse cardiac events)
Description
The development of MACE: Death, myocardial infarction, hospitalization due to heart failure, recurrent PCI or CABG.
Time Frame
3 and 6 months after procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
TIMI 2-3 flow in the infarct related artery (IRA) with high thrombus burden at initial angiography.
TIMI 2-3 in the IRA with high thrombus burden after MIMI.
Exclusion Criteria:
TIMI 0-1 flow in the IRA after MIMI.
TIMI 2-3 in the IRA with low thrombus burden.
Contraindication or hypersensitivity to Tirofiban
High bleeding risk calculated using the CRUSADE score >50.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yomna S Abdelrehim, Master student
Phone
01157090118
Ext
+20
Email
yomnashokry@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ayman Khairy, Prof
Phone
0109 443 8055
Ext
+20
Email
aymankhairy11@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Abdelghany, Prof
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayman Khairy, Prof
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17692740
Citation
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Results Reference
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PubMed Identifier
19490354
Citation
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Results Reference
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PubMed Identifier
33357638
Citation
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Results Reference
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PubMed Identifier
12377860
Citation
Yip HK, Chen MC, Chang HW, Hang CL, Hsieh YK, Fang CY, Wu CJ. Angiographic morphologic features of infarct-related arteries and timely reperfusion in acute myocardial infarction: predictors of slow-flow and no-reflow phenomenon. Chest. 2002 Oct;122(4):1322-32. doi: 10.1378/chest.122.4.1322.
Results Reference
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PubMed Identifier
33897834
Citation
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Citation
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Results Reference
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In-hospital Clinical Outcome of Deferred Stenting Versus Immediate Stenting in the Management of Acute STEMI Presenting With High Thrombus Burden.
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