Aspiration Device in Myocardial Infarction Trial | NCT00370578

Studies
Aspiration Device in Myocardial Infarction Trial

NCT00370578

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Aug 28, 2007Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Angioplasty

Interventions

repeated thrombus aspiration during primary PCI

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Yoav Turgeman MD

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Jun 2008Estimated

First Submitted Date

Aug 9, 2006

First Submission Date that Met QC Criteria

Aug 30, 2006

First Posted Date

Aug 31, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2007

Last Update Posted Date

Aug 28, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
repeated thrombus aspiration during primary PCI	Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Efficacy of using aspiration device after every stage of Primary angiplasty

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YOAV TURGEMAN, MD	Contact	972-46494016	5264	yoav_t@clalit.org.il
LIMOR ILAN- BUSHARI, MD	Contact	972-46495273	5273	limor_il@clalit.org.il

Overall Officials

Name	Affiliation	Role
Yoav Turgeman, MD	Technion-school of medicine, Haifa, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HaEmek Medical Center	Recruiting	Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000072657	ST Elevation Myocardial Infarction
D013927	Thrombosis

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided