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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.

Primary Purpose

Coronary Thrombosis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Primary Percutaneous coronary angiography
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Thrombosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 19, 2022
    Last Updated
    December 3, 2022
    Sponsor
    Assiut University
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    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
    background
    PubMed Identifier
    19490354
    Citation
    Miranda-Guardiola F, Rossi A, Serra A, Garcia B, Rumoroso JR, Iniguez A, Vaquerizo B, Triano JL, Sierra G, Bruguera J; Spanish AMIcath Registry. Angiographic quantification of thrombus in ST-elevation acute myocardial infarction presenting with an occluded infarct-related artery and its relationship with results of percutaneous intervention. J Interv Cardiol. 2009 Jun;22(3):207-15. doi: 10.1111/j.1540-8183.2009.00464.x. Epub 2009 Apr 14.
    Results Reference
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    PubMed Identifier
    33357638
    Citation
    Kumar V, Sharma AK, Kumar T, Nath RK. Large intracoronary thrombus and its management during primary PCI. Indian Heart J. 2020 Nov-Dec;72(6):508-516. doi: 10.1016/j.ihj.2020.11.009. Epub 2020 Nov 19.
    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
    Pradhan A, Bhandari M, Vishwakarma P, Sethi R. Deferred Stenting for Heavy Thrombus Burden During Percutaneous Coronary Intervention for ST-Elevation MI. Eur Cardiol. 2021 Mar 30;16:e08. doi: 10.15420/ecr.2020.31. eCollection 2021 Feb.
    Results Reference
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    PubMed Identifier
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    Citation
    Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
    Results Reference
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    PubMed Identifier
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    Citation
    Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987 Jul;76(1):142-54. doi: 10.1161/01.cir.76.1.142.
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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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