Aspiration Device in Myocardial Infarction Trial

Angioplasty Clinical Trial

Official title:

Aspiration Device Myocardial Infarction Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00370578
• Other study ID #: HaE064990ctil
• Secondary ID: Yoav Turgeman MD
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2006
• Last updated: August 27, 2007
• Start date: September 2006
• Est. completion date: June 2008

Study information

• Verified date: August 2006
• Source: HaEmek Medical Center, Israel
• Contact: YOAV TURGEMAN, MD
• Phone: 972-46494016
• Email: yoav_t[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty
• Myocardial Infarction

Intervention

Device:
• repeated thrombus aspiration during primary PCI

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limitation of infarct size
Primary	Early and follow up related (MACE)-major adverse cardiac events
Secondary	Efficacy of using aspiration device after every stage of Primary angiplasty