NCT00675480

Brief Summary

The purpose of the study is to determine whether thrombus removal with aspiration thrombectomy for acute myocardial infarction reduces the infarct size.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

3.8 years

First QC Date

May 7, 2008

Last Update Submit

January 28, 2009

Conditions

Acute Myocardial Infarction

Keywords

myocardial infarction, thrombectomy, salvage index

Outcome Measures

Primary Outcomes (1)

  • Myocardial salvage index assessed with SPECT MIBI.

    5-8 days

Secondary Outcomes (4)

  • In hospital mortality

    in hospital, before discharge

  • ST segment resolution after PCI;

    90 minutes

  • CK-MB AUC

    72 hours

  • Corrected TIMI frame count

    immediately post PCI

Study Arms (2)

T

EXPERIMENTAL

Patients treated with thrombectomy: T

Procedure: Thrombectomy

P

ACTIVE COMPARATOR

Patients treated with standard PCI with stent implantation

Procedure: Primary angioplasty

Interventions

ThrombectomyPROCEDURE

Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction

Also known as: Rescue (Boston Scientific), Diver (Invatec)
T
Primary angioplastyPROCEDURE

Standard primary angioplasty with stent implantation

Also known as: Bare metal stent implanted during primary angioplasty
P

Eligibility Criteria

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

You may qualify if:

  • First acute myocardial infarction with ST segment elevation within 12 hours from pain onset
  • Culprit lesion in left anterior descending or right coronary artery.
  • Coronary flow assessed in TIMI scale ≤ 2
  • Presence of total coronary occlusion or angiographically visible thrombus in the culprit vessel
  • Patient signed informed consent

You may not qualify if:

  • Cardiogenic shock.
  • Culprit lesion in left circumflex coronary artery.
  • Status post coronary artery by-pass grafting
  • Previous myocardial infarction
  • Status post percutaneous coronary intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiology

Warsaw, 04-628, Poland

Location

Related Publications (1)

  • Ciszewski M, Pregowski J, Teresinska A, Karcz M, Kalinczuk L, Pracon R, Witkowski A, Ruzyllo W. Aspiration coronary thrombectomy for acute myocardial infarction increases myocardial salvage: single center randomized study. Catheter Cardiovasc Interv. 2011 Oct 1;78(4):523-31. doi: 10.1002/ccd.22933. Epub 2011 Jun 6.

    PMID: 21234920DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Michal Ciszewski, MD, PhD

    National Institute of Cardiology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 9, 2008

Study Start

November 1, 2004

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

PL(1)