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

December 3, 2022 updated by: Yomna Mahmoud Shokry Abdelrehim, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  1. Large infarct-related artery (visually estimated reference vessel diameter ≥ 4 mm)
  2. Angiographic thrombus with the greatest linear dimension > 3 times the reference vessel diameter;
  3. "Cutoff pattern" (lesion morphology with an abrupt cutoff without taper before the occlusion);
  4. Accumulated thrombus (> 5 mm of linear dimension) proximal to the occlusion;
  5. Floating thrombus proximal to the occlusion;
  6. 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.

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Phase 2

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:

  1. TIMI 2-3 flow in the infarct related artery (IRA) with high thrombus burden at initial angiography.
  2. TIMI 2-3 in the IRA with high thrombus burden after MIMI.

Exclusion Criteria:

  1. TIMI 0-1 flow in the IRA after MIMI.
  2. TIMI 2-3 in the IRA with low thrombus burden.
  3. Contraindication or hypersensitivity to Tirofiban
  4. High bleeding risk calculated using the CRUSADE score >50.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI
Procedure: Primary Percutaneous coronary angiography
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.
Other Names:
  • Minimally invasive mechanical intervention
Active Comparator: Non-deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI
Procedure: Primary Percutaneous coronary angiography
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.
Other Names:
  • Minimally invasive mechanical intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of the method used in terms of TIMI flow
Time Frame: During in hospital stay up to 36 hours
By TIMI III flow finding
During in hospital stay up to 36 hours
Effectiveness of the method used in regards to ECG.
Time Frame: During in hospital stay up to 36 hours
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.
Time Frame: During in hospital stay up to 36 hours
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.
Time Frame: During in hospital stay up to 36 hours
Death during hospital stay post-PCI.
During in hospital stay up to 36 hours
Safety of the method used in regards to bleeding.
Time Frame: During in hospital stay up to 36 hours
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.
Time Frame: During in hospital stay up to 36 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow up post-PCI by trans-thoracic Echo
Time Frame: During in hospital stay up to 36 hours
To estimate the ejection fraction on discharge.
During in hospital stay up to 36 hours
Follow up post-PCI in regards to MACE (Major adverse cardiac events)
Time Frame: 3 and 6 months after procedure
The development of MACE: Death, myocardial infarction, hospitalization due to heart failure, recurrent PCI or CABG.
3 and 6 months after procedure

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Mohammed Abdelghany, Prof, Assiut University
  • Study Director: Ayman Khairy, Prof, 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)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

November 19, 2022

First Submitted That Met QC Criteria

December 3, 2022

First Posted (Estimate)

December 12, 2022

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 3, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPCI in STEMI

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 Coronary Thrombosis

Clinical Trials on Primary Percutaneous coronary angiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe