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Aspiration Device in Myocardial Infarction Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00370578
First received: August 9, 2006
Last updated: August 27, 2007
Last verified: August 2006
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aspiration Device Myocardial Infarction Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00370578     History of Changes
Other Study ID Numbers: HaE064990ctil, Yoav Turgeman MD
Study First Received: August 9, 2006
Last Updated: August 27, 2007
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on May 22, 2013