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Aspiration Device in Myocardial Infarction Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370578
First Posted: August 31, 2006
Last Update Posted: August 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
HaEmek Medical Center, Israel
  Purpose

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.


Condition Intervention
Angioplasty Device: repeated thrombus aspiration during primary PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aspiration Device Myocardial Infarction Trial

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Limitation of infarct size
  • Early and follow up related (MACE)-major adverse cardiac events

Secondary Outcome Measures:
  • Efficacy of using aspiration device after every stage of Primary angiplasty

Estimated Enrollment: 100
Study Start Date: September 2006
Estimated Study Completion Date: June 2008
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370578


Contacts
Contact: YOAV TURGEMAN, MD 972-46494016 ext 5264 yoav_t@clalit.org.il
Contact: LIMOR ILAN- BUSHARI, MD 972-46495273 ext 5273 limor_il@clalit.org.il

Locations
Israel
HaEmek Medical Center Recruiting
Afula, Israel, 18101
Contact: Khalid Suleiman, MD    972-46494017 ext 4017    sulieman_k@clalit.org.il   
Contact: Alexander Feldman, MD    972-46495585    feldman_a@clalit.org.il   
Sub-Investigator: Shaul Atar, MD         
Sub-Investigator: Nahum A Freedberg, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Yoav Turgeman, MD Technion-school of medicine, Haifa, Israel
  More Information

ClinicalTrials.gov Identifier: NCT00370578     History of Changes
Other Study ID Numbers: HaE064990ctil
Yoav Turgeman MD
First Submitted: August 9, 2006
First Posted: August 31, 2006
Last Update Posted: August 28, 2007
Last Verified: August 2006

Keywords provided by HaEmek Medical Center, Israel:
STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases