In-hospital Clinical Outcome of Deferred Stenting Versus Immediate Stenting in the Management of Acute STEMI Presenting With High Thrombus Burden.

NCT05647018 | Unknown Phase 2

• 1 other identifier: PPCI in STEMI
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Thrombosis

Outcome Measures

Primary Outcomes (6)

• Effectiveness of the method used in terms of TIMI flow

  By TIMI III flow finding

  During in hospital stay up to 36 hours

• Effectiveness of the method used in regards to ECG.

  ECG: ST segment resolution immediately after PCI and 90 minutes after PCI

  During in hospital stay up to 36 hours

• Effectiveness of the method used in regards to development of heart failure.

  Development of acute heart failure after PCI during hospital admission.

  During in hospital stay up to 36 hours

• Effectiveness of the method used in regards to mortality.

  Death during hospital stay post-PCI.

  During in hospital stay up to 36 hours

• 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

  During in hospital stay up to 36 hours

• 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.

  During in hospital stay up to 36 hours

Secondary Outcomes (2)

• Follow up post-PCI by trans-thoracic Echo

  During in hospital stay up to 36 hours

• Follow up post-PCI in regards to MACE (Major adverse cardiac events)

  3 and 6 months after procedure

Study Arms (2)

Deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI

ACTIVE COMPARATOR

Procedure: Primary Percutaneous coronary angiography

Non-deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI

ACTIVE COMPARATOR

Procedure: Primary Percutaneous coronary angiography

Interventions

Primary Percutaneous coronary angiography PROCEDURE

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.

Also known as: Minimally invasive mechanical intervention

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• 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.

  PMID: 17692740 BACKGROUND

• 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.

  PMID: 19490354 BACKGROUND

• 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.

  PMID: 33357638 BACKGROUND

• 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.

  PMID: 12377860 BACKGROUND

• 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.

  PMID: 33897834 BACKGROUND

• 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.

  PMID: 28886621 BACKGROUND

• 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.

  PMID: 3109764 BACKGROUND

• Vranckx P, White HD, Huang Z, Mahaffey KW, Armstrong PW, Van de Werf F, Moliterno DJ, Wallentin L, Held C, Aylward PE, Cornel JH, Bode C, Huber K, Nicolau JC, Ruzyllo W, Harrington RA, Tricoci P. Validation of BARC Bleeding Criteria in Patients With Acute Coronary Syndromes: The TRACER Trial. J Am Coll Cardiol. 2016 May 10;67(18):2135-2144. doi: 10.1016/j.jacc.2016.02.056.

  PMID: 27151345 BACKGROUND

MeSH Terms

Conditions

Coronary Thrombosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Mohammed Abdelghany, Prof

  Assiut University

  STUDY DIRECTOR

• Ayman Khairy, Prof

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Yomna S Abdelrehim, Master student

CONTACT

01157090118; yomnashokry@yahoo.com

Ayman Khairy, Prof

CONTACT

0109 443 8055; aymankhairy11@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: November 19, 2022
• First Posted: December 12, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 30, 2024
• Last Updated: December 12, 2022

Record last verified: 2022-12