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Clinical Trials/NCT05510661
NCT05510661Active, not recruitingNot Applicable

Use of Export in Primary Percutaneous Coronary Intervention, In-Hospital and Short-term Outcomes and Optimal Time of Export

National Institute of Cardiovascular Diseases, Pakistan1 site in 1 country300 target enrollmentStarted: January 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
300
Locations
1
Primary Endpoint
Slow/No-reflow

Study Overview

Brief Summary

Aim of this single center randomized open label trial with blinded in-hospital outcomes assessment is designed with aim to compare manual thrombus aspiration followed by percutaneous coronary intervention (PCI) strategy with PCI alone.

Detailed Description

Clinical benefit of manual aspiration has been a contentious point of debate and it is Class III indication in current clinical practice guidelines, however, recent observational data by Kumar D et al. showed benefits of usage of export in terms of favorable in-hospital outcomes and lesser complication rate in patients with total occlusion, furthermore, benefits of usage of export was observed to be directly associated with duration of chest pain at the time of thrombus aspiration. However, these observations are limited to immediate and in-hospital outcomes and data regarding efficacy of manual thrombus aspiration are not available.

Hence this single center randomized open label trial is designed with specific aim to test the following hypothesis for STEMI patients with total occlusion undergoing primary PCI;

  • Whether use of export catheter reduces in-hospital and short term adverse events
  • Whether use of export reduces slow flow or no reflow
  • Whether use of export reduces the use of intracoronary drugs
  • Whether use of export within 6 hours of symptom onset significantly reduces in-hospital and short term adverse events

Consecutively recruited patients will be randomized to either primary PCI with export or primary PCI alone group in 2:1 ratio. Post aspiration immediate TIMI flow will be observed and all the patients will be observed for adverse outcomes (MACE) and complications including slow flow/no-reflow. Follow-up intervals will be at the end of one month of randomization and end of 6 month of randomization.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Blinded in-hospital outcomes assessment will be insured by separating patients recruitment and follow-up team and follow-up team will be kept blinded of randomization. All the patients will be assigned a unique identity code and collected data will be stored against the assigned code.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes
  • •Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
  • •Chest pain < 12 hours duration
  • •Total occlusion (TIMI 0 flow)
  • •Patients undergoing primary PCI
  • •Informed consent

Exclusion Criteria

  • •Patients with prior history of cardiac related surgery or intervention
  • •Performance of a rescue PCI after thrombolysis
  • •Known existence of a disease resulting in a life expectancy of less than 6 months
  • •Killip class III, IV

Arms & Interventions

Intervention Group

Experimental

Manual thrombus aspiration (use of export catheter) followed by primary PCI

Intervention: Export Catheter (Device)

Control group

Active Comparator

Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI

Intervention: Balloon catheter (Device)

Outcomes

Primary Outcomes

Slow/No-reflow

Time Frame: Immediately after procedure

TIMI 0-II flow

Post thrombus aspiration TIMI flow

Time Frame: Immediately after export/balloon

Immediate TIMI flow after export/balloon

Major adverse cardiac events

Time Frame: In-hospital, at 1 month, and at 6 months

It will include All-cause death, Cardiovascular death, Re- infarction, Heart Failure, Cardiogenic shock, Cerebrovascular events, Bleeding events, and Stent thrombosis

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Faiza Farooq

Acting Associate Professor

National Institute of Cardiovascular Diseases, Pakistan

Study Sites (1)

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