NCT01824641

Brief Summary

The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus aspiration compared to conventional PCI group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

September 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

March 22, 2013

Last Update Submit

April 2, 2013

Conditions

Myocardial Infarction

Keywords

Acute myocardial infarctionManual thrombus aspirationCoronary physiology

Outcome Measures

Primary Outcomes (1)

  • IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group

    IMR will be measured after final balloon inflation or stent implantation, an expected average of 45 minutes after sheath insertion

    At the end of the primary PCI , an expected average of 45 minutes after sheath insertion

Secondary Outcomes (5)

  • Resolution of ST-segment elevation

    at 60 minutes after guiding catheter removal

  • myocardial blush grade (0-3)

    at final angiogram, an expected average of 55 minutes after sheath insertion

  • infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB))

    in hospital course after primary PCI, an expected average of 5 days

  • indices of left ventricle remodeling on Echocardiography

    within 24 hours and at 4 months after primary PCI

  • infarct size determined by SPECT

    within 7-14 days and at 4 months after primary PCI

Study Arms (2)

Eliminate

EXPERIMENTAL

Eliminate aspiration catheter

Device: Eliminate aspiration catheter

Conventional primary angioplasty

ACTIVE COMPARATOR

Patients treated with conventional primary angioplasty

Procedure: Conventional primary angioplasty

Interventions

Eliminate aspiration catheterDEVICE

Eliminate aspiration catheter

Eliminate
Conventional primary angioplastyPROCEDURE

Primary angioplasty without thrombus aspiration

Conventional primary angioplasty

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All consecutive patients with STEMI
  • chest pain onset ≤12h, or \>12 h with persistent ST-segment elevation
  • hemodynamically stable patients

You may not qualify if:

  • patients without diagnosis of STEMI (pericarditis, for example)
  • no written informed consent obtained
  • prior Q or non-Q MI
  • prior resuscitation
  • prior thrombolysis
  • prior surgical myocardial revascularisation
  • life expectancy \<6 months
  • periprocedural death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical center of Serbia

Belgrade, 11000, Serbia

RECRUITING

Clinical Center of Serbia

Belgrade, Serbia

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Dejan Orlic, MD

    Clinical Center of Serbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dejan Milasinovic, MD

CONTACT

+381113613653dejan_milasinovic@yahoo.com

Goran Stankovic, MD, PhD

CONTACT

+381113615433gorastan@sbb.rs

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 22, 2013

First Posted

April 5, 2013

Study Start

September 1, 2012

Primary Completion

May 1, 2013

Study Completion

November 1, 2013

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

SE(2)