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Follow up of Clinical Outcome of Deferred vs Immediate Stenting in High Thrombus Stemi Patients

Primary Purpose

STEMI

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PPCI in heavy thrombus burden STEMI patients
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI focused on measuring STEMI patients, Heavy thrombus burden, Deferred stenting, Clinical follow up

Eligibility Criteria

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

Inclusion Criteria: Primary percutaneous coronary intervention (PPCI) patients with culprit vessels shows heavy thrombus burden lesions. Culprit vessels with TIMI 2-3 either from the beginning or after MIMI (Minimalist immediate mechanical intervention). Exclusion Criteria: PPCI patients with low thrombus burden lesions. PPCI patient with heavy thrombus burden lesions but with culprit vessels TIMI score 0-1, didn't improve after MIMI. patients killip II /III /IV

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    immediate stenting in heavy thrombus STEMI burden patients

    Deferred stenting in heavy thrombus burden STEMI patients .

    Arm Description

    This group - heavy thrombus burden STEMI patients with thrombolysis in myocardial infarction ( TIMI ) 2-3 flow - will receive loading dose of GPIIbIIIa inhibitor intracoronary followed by immediate stenting .

    This group - heavy thrombus burden STEMI patients with TIMI 2-3 flow - will receive loading dose of GPIIbIIIa inhibitor intracoronary followed by GPIIbIIIa inhibitor infusion and LMWH administration for 48 -72 hours followed by stenting .

    Outcomes

    Primary Outcome Measures

    Number of patients who develops major adverse cardiovascular events 3 months post PPCI .
    Major adverse cardiovascular events include re-infarction, repeat PCI, CABG, Congestive heart failure, cardiac death & CVS accidents.
    Number of patients who develops major adverse cardiovascular events 6 months post PPCI .
    Major adverse cardiovascular events include re-infarction, repeat PCI, CABG, Congestive heart failure, cardiac death & CVS accidents.

    Secondary Outcome Measures

    Number of patients who develop major bleeding
    major bleeding defined by bleeding in critical area , fatal bleeding , loos in hemoglobin more than 5 gm/dl .
    number of patients who develop contrast induced nephropathy
    impaired renal function tests including creatinine and urea after contrast use .
    Number of patients who develop allergy to tirofiban
    developing rash , angioedema , dyspnea as a reaction to tirofiban

    Full Information

    First Posted
    March 1, 2023
    Last Updated
    March 30, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05793671
    Brief Title
    Follow up of Clinical Outcome of Deferred vs Immediate Stenting in High Thrombus Stemi Patients
    Official Title
    Short Term Clinical and Major Cardiovascular Adverse Events of Deferred Versus Immediate Stenting in High Thrombus Burden STEMI Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 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 effect of immediate stenting versus deferred stenting - with use of glycoproteinIIbIIIa inhibitor & low molecular weight heparin - on the clinical outcome -3 and 6 months after stenting & also infarct size using troponin level during hospital stay . Clinical outcome - 3 and 6 months - after stenting which includes re-infarction, repeat percutaneous coronary intervention, coronary artery bypass grafting , Congestive heart failure, cardiac death & cerebrovascular accidents.
    Detailed Description
    Myocardial infarct¬¬¬ion is myocardial necrosis associated with impaired blood perfusion . Until now primary percutaneous coronary intervention (PPCI) is the standard modality of myocardial reperfusion However, there are a considerable number of patients whom still had acute reduction in myocardial blood perfusion after stent implantation even with patent epicardial artery which was defined as "no-reflow" That was explained by the affection of the micro-vasculature. With manipulation of culprit coronary artery lesion, distal embolization can occur, causing micro-vascular embolization & spasm which will significantly affect myocardial perfusion even with patent epicardial coronary artery Multiple methods were tried to decrease the chances of "no reflow phenomenon". Distal protection devices were used, but unfortunately with no promising results Routine thrombectomy is still controversial. Deferred stenting, there is still controversy about the use of this strategy. At some studies, immediate stenting in thrombotic context was associated with no-reflow &distal embolization So ideas about deferred stenting started to glow when Isaac et al tried stenting deferral, after restoring culprit coronary artery patency using minimalist immediate mechanical intervention known as "MIMI - minimalist immediate mechanical intervention -" . That gave green light for further studies to explore benefits and risks of deferred stenting. However , the strategy is still controversial , as some studies support the use of deferred stenting strategy and found it associated with better endpoints as, reduced no reflow , better myocardial perfusion and salvage lower major adverse cardiovascular events (MACE) , better left ventricular function However there were other studies which showed no beneficial effect of deferred stenting, but even affect badly the micro-vascular obstruction. Reasons for these conflicting results included: Category of patients included where deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI) enrolled patients at high risk of slow flow based on clinical angiographic features, whereas DANAMI-3 DEFER was all-corner primary PCI study. A deferral strategy should only be applied after careful angiographic selection. DEFER-STEMI was angiographic and MRI end-point study whereas DANAMI 3-DEFER looked at clinical outcomes. DANAMI 3-DEFER was a larger multi-center randomized study in contrast to DEFER-STEMI. The use of GPIIbIIIa inhibitors in Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER) was significantly lower compared to DEFERED-STEMI. There was high crossover to immediate stenting in the defer arm of DANAMI trial which further weakened the results.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    STEMI
    Keywords
    STEMI patients, Heavy thrombus burden, Deferred stenting, Clinical follow up

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Closed letters will be provided in cath-lab , inside of each letter , there is a paper with decision written --> either go for stent ( for immediate stenting ) or don't go for stent ( for non-deferred stenting)
    Allocation
    Randomized
    Enrollment
    440 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    immediate stenting in heavy thrombus STEMI burden patients
    Arm Type
    Active Comparator
    Arm Description
    This group - heavy thrombus burden STEMI patients with thrombolysis in myocardial infarction ( TIMI ) 2-3 flow - will receive loading dose of GPIIbIIIa inhibitor intracoronary followed by immediate stenting .
    Arm Title
    Deferred stenting in heavy thrombus burden STEMI patients .
    Arm Type
    Active Comparator
    Arm Description
    This group - heavy thrombus burden STEMI patients with TIMI 2-3 flow - will receive loading dose of GPIIbIIIa inhibitor intracoronary followed by GPIIbIIIa inhibitor infusion and LMWH administration for 48 -72 hours followed by stenting .
    Intervention Type
    Device
    Intervention Name(s)
    PPCI in heavy thrombus burden STEMI patients
    Intervention Description
    minimally invasive procedures used to open clogged coronary arteries
    Primary Outcome Measure Information:
    Title
    Number of patients who develops major adverse cardiovascular events 3 months post PPCI .
    Description
    Major adverse cardiovascular events include re-infarction, repeat PCI, CABG, Congestive heart failure, cardiac death & CVS accidents.
    Time Frame
    3 months post PPCI
    Title
    Number of patients who develops major adverse cardiovascular events 6 months post PPCI .
    Description
    Major adverse cardiovascular events include re-infarction, repeat PCI, CABG, Congestive heart failure, cardiac death & CVS accidents.
    Time Frame
    6 months post PPCI
    Secondary Outcome Measure Information:
    Title
    Number of patients who develop major bleeding
    Description
    major bleeding defined by bleeding in critical area , fatal bleeding , loos in hemoglobin more than 5 gm/dl .
    Time Frame
    Within hospital admission
    Title
    number of patients who develop contrast induced nephropathy
    Description
    impaired renal function tests including creatinine and urea after contrast use .
    Time Frame
    Within hospital admission
    Title
    Number of patients who develop allergy to tirofiban
    Description
    developing rash , angioedema , dyspnea as a reaction to tirofiban
    Time Frame
    Within hospital admission
    Other Pre-specified Outcome Measures:
    Title
    Number of patients who develop severe thrombocytopenia
    Description
    platelets lower than 50000 per microliter of blood
    Time Frame
    Within hospital admission

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary percutaneous coronary intervention (PPCI) patients with culprit vessels shows heavy thrombus burden lesions. Culprit vessels with TIMI 2-3 either from the beginning or after MIMI (Minimalist immediate mechanical intervention). Exclusion Criteria: PPCI patients with low thrombus burden lesions. PPCI patient with heavy thrombus burden lesions but with culprit vessels TIMI score 0-1, didn't improve after MIMI. patients killip II /III /IV
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andro Thabet Fawzy, Bachelor
    Phone
    +201200012699
    Email
    Thabetandro70@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    D A F, professor
    Phone
    01001085828
    Email
    Fouaddoaa@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Doaa A. Fouad, professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18559715
    Citation
    Jaffe R, Charron T, Puley G, Dick A, Strauss BH. Microvascular obstruction and the no-reflow phenomenon after percutaneous coronary intervention. Circulation. 2008 Jun 17;117(24):3152-6. doi: 10.1161/CIRCULATIONAHA.107.742312. No abstract available.
    Results Reference
    background
    PubMed Identifier
    15741528
    Citation
    Stone GW, Webb J, Cox DA, Brodie BR, Qureshi M, Kalynych A, Turco M, Schultheiss HP, Dulas D, Rutherford BD, Antoniucci D, Krucoff MW, Gibbons RJ, Jones D, Lansky AJ, Mehran R; Enhanced Myocardial Efficacy and Recovery by Aspiration of Liberated Debris (EMERALD) Investigators. Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomized controlled trial. JAMA. 2005 Mar 2;293(9):1063-72. doi: 10.1001/jama.293.9.1063.
    Results Reference
    background
    PubMed Identifier
    18308157
    Citation
    Kelbaek H, Terkelsen CJ, Helqvist S, Lassen JF, Clemmensen P, Klovgaard L, Kaltoft A, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Thuesen L. Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial. J Am Coll Cardiol. 2008 Mar 4;51(9):899-905. doi: 10.1016/j.jacc.2007.10.047.
    Results Reference
    background
    PubMed Identifier
    18539223
    Citation
    Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8.
    Results Reference
    background
    PubMed Identifier
    16801464
    Citation
    Kaltoft A, Bottcher M, Nielsen SS, Hansen HH, Terkelsen C, Maeng M, Kristensen J, Thuesen L, Krusell LR, Kristensen SD, Andersen HR, Lassen JF, Rasmussen K, Rehling M, Nielsen TT, Botker HE. Routine thrombectomy in percutaneous coronary intervention for acute ST-segment-elevation myocardial infarction: a randomized, controlled trial. Circulation. 2006 Jul 4;114(1):40-7. doi: 10.1161/CIRCULATIONAHA.105.595660. Epub 2006 Jun 26.
    Results Reference
    background
    PubMed Identifier
    17692740
    Citation
    Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.
    Results Reference
    background
    PubMed Identifier
    26865998
    Citation
    Lim SY. No-Reflow Phoenomenon by Intracoronary Thrombus in Acute Myocardial Infarction. Chonnam Med J. 2016 Jan;52(1):38-44. doi: 10.4068/cmj.2016.52.1.38. Epub 2016 Jan 19.
    Results Reference
    background
    PubMed Identifier
    30745923
    Citation
    Alidoosti M, Lotfi R, Lotfi-Tokaldany M, Nematipour E, Salarifar M, Poorhosseini H, Jalali A. Correlates of the "No-Reflow" or "Slow-Flow" Phenomenon in Patients Undergoing Primary Percutaneous Coronary Intervention. J Tehran Heart Cent. 2018 Jul;13(3):108-114.
    Results Reference
    background
    PubMed Identifier
    12090749
    Citation
    Henriques JP, Zijlstra F, Ottervanger JP, de Boer MJ, van 't Hof AW, Hoorntje JC, Suryapranata H. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002 Jul;23(14):1112-7. doi: 10.1053/euhj.2001.3035.
    Results Reference
    background
    PubMed Identifier
    16728877
    Citation
    Isaaz K, Robin C, Cerisier A, Lamaud M, Richard L, Da Costa A, Sabry MH, Gerenton C, Blanc JL. A new approach of primary angioplasty for ST-elevation acute myocardial infarction based on minimalist immediate mechanical intervention. Coron Artery Dis. 2006 May;17(3):261-9. doi: 10.1097/00019501-200605000-00010.
    Results Reference
    background
    PubMed Identifier
    22968214
    Citation
    Ke D, Zhong W, Fan L, Chen L. Delayed versus immediate stenting for the treatment of ST-elevation acute myocardial infarction with a high thrombus burden. Coron Artery Dis. 2012 Nov;23(7):497-506. doi: 10.1097/MCA.0b013e328358a5ad.
    Results Reference
    background
    PubMed Identifier
    24583294
    Citation
    Carrick D, Oldroyd KG, McEntegart M, Haig C, Petrie MC, Eteiba H, Hood S, Owens C, Watkins S, Layland J, Lindsay M, Peat E, Rae A, Behan M, Sood A, Hillis WS, Mordi I, Mahrous A, Ahmed N, Wilson R, Lasalle L, Genereux P, Ford I, Berry C. A randomized trial of deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI). J Am Coll Cardiol. 2014 May 27;63(20):2088-2098. doi: 10.1016/j.jacc.2014.02.530. Epub 2014 Feb 27.
    Results Reference
    background
    PubMed Identifier
    26838663
    Citation
    Pascal J, Veugeois A, Slama M, Rahal S, Belle L, Caussin C, Amabile N. Delayed Stenting for ST-Elevation Acute Myocardial Infarction in Daily Practice: A Single-Centre Experience. Can J Cardiol. 2016 Aug;32(8):988-95. doi: 10.1016/j.cjca.2015.09.015. Epub 2015 Sep 26.
    Results Reference
    background
    PubMed Identifier
    27053444
    Citation
    Kelbaek H, Hofsten DE, Kober L, Helqvist S, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, De Backer O, Bang LE, Kofoed KF, Lonborg J, Ahtarovski K, Vejlstrup N, Botker HE, Terkelsen CJ, Christiansen EH, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Jensen LO, Clemmensen P, Grande P, Madsen JK, Torp-Pedersen C, Engstrom T. Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER): an open-label, randomised controlled trial. Lancet. 2016 May 28;387(10034):2199-206. doi: 10.1016/S0140-6736(16)30072-1. Epub 2016 Apr 3.
    Results Reference
    background
    PubMed Identifier
    26957418
    Citation
    Belle L, Motreff P, Mangin L, Range G, Marcaggi X, Marie A, Ferrier N, Dubreuil O, Zemour G, Souteyrand G, Caussin C, Amabile N, Isaaz K, Dauphin R, Koning R, Robin C, Faurie B, Bonello L, Champin S, Delhaye C, Cuilleret F, Mewton N, Genty C, Viallon M, Bosson JL, Croisille P; MIMI Investigators*. Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. Circ Cardiovasc Interv. 2016 Mar;9(3):e003388. doi: 10.1161/CIRCINTERVENTIONS.115.003388.
    Results Reference
    background

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