NCT05793671

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 1, 2023

Last Update Submit

March 30, 2023

Conditions

STEMI

Keywords

STEMI patientsHeavy thrombus burdenDeferred stentingClinical follow up

Outcome Measures

Primary Outcomes (2)

  • 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.

    3 months post PPCI

  • 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.

    6 months post PPCI

Secondary Outcomes (3)

  • Number of patients who develop major bleeding

    Within hospital admission

  • number of patients who develop contrast induced nephropathy

    Within hospital admission

  • Number of patients who develop allergy to tirofiban

    Within hospital admission

Other Outcomes (1)

  • Number of patients who develop severe thrombocytopenia

    Within hospital admission

Study Arms (2)

immediate stenting in heavy thrombus STEMI burden patients

ACTIVE COMPARATOR

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 .

Device: PPCI in heavy thrombus burden STEMI patients

Deferred stenting in heavy thrombus burden STEMI patients .

ACTIVE COMPARATOR

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 .

Device: PPCI in heavy thrombus burden STEMI patients

Interventions

PPCI in heavy thrombus burden STEMI patientsDEVICE

minimally invasive procedures used to open clogged coronary arteries

Deferred stenting in heavy thrombus burden STEMI patients .immediate stenting in heavy thrombus STEMI burden patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • 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.

    PMID: 18559715BACKGROUND

  • 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.

    PMID: 15741528BACKGROUND

  • 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.

    PMID: 18308157BACKGROUND

  • 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.

    PMID: 18539223BACKGROUND

  • 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.

    PMID: 16801464BACKGROUND

  • 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: 17692740BACKGROUND

  • 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.

    PMID: 26865998BACKGROUND

  • 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.

    PMID: 30745923BACKGROUND

  • 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.

    PMID: 12090749BACKGROUND

  • 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.

    PMID: 16728877BACKGROUND

  • 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.

    PMID: 22968214BACKGROUND

  • 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.

    PMID: 24583294BACKGROUND

  • 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.

    PMID: 26838663BACKGROUND

  • 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.

    PMID: 27053444BACKGROUND

  • 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.

    PMID: 26957418BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Doaa A. Fouad, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Andro Thabet Fawzy, Bachelor

CONTACT

+201200012699Thabetandro70@gmail.com

D A F, professor

CONTACT

01001085828Fouaddoaa@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 31, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share