NCT01384019

Brief Summary

The investigators examined the mechanism underlying the lack of benefit from distal protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial Infarction (STEMI) in a prospective, randomized trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

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

January 1, 2004

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 18, 2013

Completed
Last Updated

March 18, 2013

Status Verified

February 1, 2013

Enrollment Period

4.4 years

First QC Date

June 27, 2011

Results QC Date

January 14, 2013

Last Update Submit

February 14, 2013

Conditions

ST-segment Elevation Myocardial Infarction

Keywords

ST-elevation myocardial infarctionpercutaneous coronary interventioncardiac magnetic resonance imagingmicrovascular occlusionmyocardial salvage

Outcome Measures

Primary Outcomes (1)

  • Postinfarct Remodeling

    postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI

    6 months

Secondary Outcomes (1)

  • Reperfusion Success

    3-5 days

Study Arms (2)

DP-TA

EXPERIMENTAL

distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)

Device: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))

c-PCI

PLACEBO COMPARATOR

conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction

Procedure: c-PCI

Interventions

distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))DEVICE

The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration

Also known as: The GuardWire Plus (Medtronic Inc.)
DP-TA
c-PCIPROCEDURE

conventional PCI without Guard wire

Also known as: convenional PCI
c-PCI

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and less than 80 years presenting with STEMI
  • more than 30 minutes but less than 12 hours after symptom onset
  • with ≥ 2 mm of ST-segment elevation in 2 or more contiguous leads or with a presumably new left bundle-branch block
  • for whom primary PCI was intended

You may not qualify if:

  • included thrombolytic therapy before PCI;
  • spontaneous restoration of coronary flow (\> TIMI grade II or III);
  • cardiogenic shock (Killip class IV);
  • major surgery or active bleeding within 6 weeks;
  • aspirin, thienopyridine, or heparin allergy;
  • neutropenia (\<1000 neutrophils/mm3), thrombocytopenia (\<100000 platelets/mm3), hepatic dysfunction, or renal insufficiency (serum creatinine level \>2.5 mg/dL \[221 μmol/L\]);
  • noncardiac condition with expected survival less than 1 year;
  • current participation in other investigations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Natioinal University Bundang Hospital

Seongnam, South Korea

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
Dr. Chang-Hwan Yoon
Organization
Seoul national university Bundang hospital
changhwanyoon@snubh.org
+82-31-787-7052

Study Officials

  • Dong-ju Choi, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of cardiovascular center

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 28, 2011

Study Start

January 1, 2004

Primary Completion

June 1, 2008

Study Completion

August 1, 2011

Last Updated

March 18, 2013

Results First Posted

March 18, 2013

Record last verified: 2013-02

Locations

KR(1)