Aspiration Device in Myocardial Infarction Trial
|ClinicalTrials.gov Identifier: NCT00370578|
Recruitment Status : Unknown
Verified August 2006 by HaEmek Medical Center, Israel.
Recruitment status was: Recruiting
First Posted : August 31, 2006
Last Update Posted : August 28, 2007
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 or disease||Intervention/treatment||Phase|
|Angioplasty||Device: repeated thrombus aspiration during primary PCI||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aspiration Device Myocardial Infarction Trial|
|Study Start Date :||September 2006|
|Estimated Study Completion Date :||June 2008|
- Limitation of infarct size
- Early and follow up related (MACE)-major adverse cardiac events
- Efficacy of using aspiration device after every stage of Primary angiplasty
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370578
|Contact: YOAV TURGEMAN, MD||972-46494016 ext email@example.com|
|Contact: LIMOR ILAN- BUSHARI, MD||972-46495273 ext firstname.lastname@example.org|
|HaEmek Medical Center||Recruiting|
|Afula, Israel, 18101|
|Contact: Khalid Suleiman, MD 972-46494017 ext 4017 email@example.com|
|Contact: Alexander Feldman, MD 972-46495585 firstname.lastname@example.org|
|Sub-Investigator: Shaul Atar, MD|
|Sub-Investigator: Nahum A Freedberg, MD|
|Principal Investigator:||Yoav Turgeman, MD||Technion-school of medicine, Haifa, Israel|