Aspiration Device in Myocardial Infarction Trial

August 27, 2007 updated by: HaEmek Medical Center, Israel

Aspiration Device Myocardial Infarction Trial

Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation (STEMI).

The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI population.

Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

ADMIT-Randomized Single Center Study with two arms:

Standard PCI versus Primary PCI, using thrombus aspiration device after ever step of the procedure.

Issues to be examined are:

  1. Immediate angiographic differences between the study arms. By evaluation of: TIMI FLOW GRADE,TIMI FRAME COUNT,MYOCARDIAL BLUSH GRADE. No reflow phenomenae,
  2. Infarc size evaluated by serum markers and non invasive parameters
  3. In hospital major adverse cardiac events
  4. Major adverse cardiac events during 30& 180 days of follow up

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Recruiting
        • Haemek Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Shaul Atar, MD
        • Sub-Investigator:
          • Nahum A Freedberg, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with STEMI<12 from synptoms onset
  • eligble for primary PCI regardless of initial TIMI flow grade.
  • patients for rescue PCI after failed thrombolysis will also be included

Exclusion Criteria:

  • womwn with known pregnancy or who are lactating
  • pts with allergy to aspirin, clopidogrel or heparin
  • inability to obtain informed consent
  • known existence of life threatening diseases with a life expectency less than 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Limitation of infarct size
Early and follow up related (MACE)-major adverse cardiac events

Secondary Outcome Measures

Outcome Measure
Efficacy of using aspiration device after every stage of Primary angiplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Yoav Turgeman, MD, Technion-school of medicine, Haifa, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

August 9, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimate)

August 31, 2006

Study Record Updates

Last Update Posted (Estimate)

August 28, 2007

Last Update Submitted That Met QC Criteria

August 27, 2007

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HaE064990ctil
  • Yoav Turgeman MD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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