Aspiration Device in Myocardial Infarction Trial
Primary Purpose
Angioplasty
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
repeated thrombus aspiration during primary PCI
Sponsored by
About this trial
This is an interventional treatment trial for Angioplasty focused on measuring STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW
Eligibility 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
Sites / Locations
- HaEmek Medical CenterRecruiting
Outcomes
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
Full Information
NCT ID
NCT00370578
First Posted
August 9, 2006
Last Updated
August 27, 2007
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00370578
Brief Title
Aspiration Device in Myocardial Infarction Trial
Official Title
Aspiration Device Myocardial Infarction Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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:
Immediate angiographic differences between the study arms. By evaluation of: TIMI FLOW GRADE,TIMI FRAME COUNT,MYOCARDIAL BLUSH GRADE. No reflow phenomenae,
Infarc size evaluated by serum markers and non invasive parameters
In hospital major adverse cardiac events
Major adverse cardiac events during 30& 180 days of follow up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioplasty
Keywords
STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
repeated thrombus aspiration during primary PCI
Primary Outcome Measure Information:
Title
Limitation of infarct size
Title
Early and follow up related (MACE)-major adverse cardiac events
Secondary Outcome Measure Information:
Title
Efficacy of using aspiration device after every stage of Primary angiplasty
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YOAV TURGEMAN, MD
Phone
972-46494016
Ext
5264
Email
yoav_t@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
LIMOR ILAN- BUSHARI, MD
Phone
972-46495273
Ext
5273
Email
limor_il@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoav Turgeman, MD
Organizational Affiliation
Technion-school of medicine, Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalid Suleiman, MD
Phone
972-46494017
Ext
4017
Email
sulieman_k@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Alexander Feldman, MD
Phone
972-46495585
Email
feldman_a@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Shaul Atar, MD
First Name & Middle Initial & Last Name & Degree
Nahum A Freedberg, MD
12. IPD Sharing Statement
Learn more about this trial
Aspiration Device in Myocardial Infarction Trial
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