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

March 30, 2023 updated by: Andro thabet fawzy, Assiut University

Short Term Clinical and Major Cardiovascular Adverse Events of Deferred Versus Immediate Stenting in High Thrombus Burden STEMI Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: immediate stenting in heavy thrombus STEMI burden patients
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
minimally invasive procedures used to open clogged coronary arteries
Active Comparator: Deferred stenting in heavy thrombus burden STEMI patients .
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
minimally invasive procedures used to open clogged coronary arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who develops major adverse cardiovascular events 3 months post PPCI .
Time Frame: 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 .
Time Frame: 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 Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who develop severe thrombocytopenia
Time Frame: Within hospital admission
platelets lower than 50000 per microliter of blood
Within hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Doaa A. Fouad, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Deferred stenting in STEMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on STEMI

Clinical Trials on PPCI in heavy thrombus burden STEMI patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe