NCT01379248

Brief Summary

The purpose of this study is to examine the benefit of thrombus aspiration in patients with ST-elevation myocardial infarction presenting late after symptom onset.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2011

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

June 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

3.4 years

First QC Date

June 20, 2011

Last Update Submit

October 27, 2016

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Microvascular obstruction (cardiac magnetic resonance imaging)

    1-4 days after randomization

Study Arms (2)

thrombus aspiration

EXPERIMENTAL

Manual thrombus aspiration with dedicated catheter (Export, Medtronic Inc. Minneapolis, Minnesota, USA)

Device: manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)

no thrombus aspiration

NO INTERVENTION

Interventions

manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)DEVICE

manual thrombus aspiration catheter to be used during percutaneous coronary intervention

thrombus aspiration

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ST-elevation myocardial infarction \>12 and \<48 hours after symptom onset
  • age 18 to 90 years
  • informed consent

You may not qualify if:

  • prior fibrinolysis
  • severe comorbidities with limited life expectancy
  • pregnancy
  • patient unable to give informed consent
  • participation in another trial
  • contraindications for heparin, aspirin or thienopyridines
  • contraindications for cardiac magnetic resonance examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig Heart Center

Leipzig, 04289, Germany

Location

Related Publications (1)

  • Desch S, Stiermaier T, de Waha S, Lurz P, Gutberlet M, Sandri M, Mangner N, Boudriot E, Woinke M, Erbs S, Schuler G, Fuernau G, Eitel I, Thiele H. Thrombus Aspiration in Patients With ST-Segment Elevation Myocardial Infarction Presenting Late After Symptom Onset. JACC Cardiovasc Interv. 2016 Jan 25;9(2):113-22. doi: 10.1016/j.jcin.2015.09.010.

    PMID: 26793952DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv. - Doz. Dr. med.

Study Record Dates

First Submitted

June 20, 2011

First Posted

June 23, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2014

Study Completion

May 1, 2015

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

DE(1)