Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction. - Full Text View

Purpose

In patients with acute ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) may cause thrombus dislodgment and impaired microcirculatory reperfusion. This study was designed to test the hypothesis that thrombus aspiration before standard PCI may improve acute myocardial reperfusion, measured by ST-segment resolution (STR) and myocardial blush grade (MBG), compared with standard PCI.

Condition	Intervention	Phase
Acute Myocardial Infarction	Device: Coronary thrombus aspiration catheter	Phase IV

MedlinePlus related topics:

Angioplasty Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Niguarda Hospital:

Primary Outcome Measures:

ST-segment resolution immediately after primary angioplasty
Myocardial Blush grade after angioplasty.

Secondary Outcome Measures:

Coronary TIMI flow grade,
distal embolization,
no reflow

Estimated Enrollment:	160
Study Start Date:	March 2004
Estimated Study Completion Date:	September 2005

Detailed Description:

Consecutive STEMI patients, admitted within 12 hours of symptom onset and scheduled for primary PCI are randomly assigned to two treatment strategies: standard PCI including stenting and abciximab (group1) or thrombus aspiration with Pronto™ extraction catheter (Vasc.solutions, Minneapolis) before standard PCI (group2). Patients with cardiogenic shock, previous infarction or thrombolytic therapy are excluded.

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ST-segment elevation myocardial infarction patients undergoing primary angioplasty within 12 hours from symptom onset.

Exclusion Criteria:

Cardiogenic shock, previous infarction, previous coronary bypass surgery,bundle branch block or pacemaker induced rythm, controindications to IIb/IIIa inhibitors.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257153

Locations


Italy
	Cardiology department, Niguarda hospital
	Milan, Italy, 20162

Sponsors and Collaborators

Niguarda Hospital

Investigators


Principal Investigator:	Pedro L Silva-Orrego, MD	Interventional cardiology laboratory, Cardiology Dpt, Niguarda Hospital

Study Chair:	Riccardo Bigi, MD	Cardiology Dpt. of medicine and surgery, University school of medicine, Milan, Italy

Study Director:	Paola Colombo	Cardiology Dpt. Niguarda hospital

Study Chair:	Silvio Klugmann, MD	cardiology Dpt. Niguarda hospital.

More Information

Publications of Results:

Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia J, Orrico P, de Biase A, Piccalo G, Bossi I, Klugmann S. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol. 2006 Oct 17;48(8):1552-9. Epub 2006 Sep 26.

Study ID Numbers:	DEAR-MI
First Received:	November 18, 2005
Last Updated:	December 1, 2006
ClinicalTrials.gov Identifier:	NCT00257153
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Niguarda Hospital:

Acute myocardial infarction

primary angioplasty

myocardial reperfusion

thrombus aspiration

Study placed in the following topic categories:

Necrosis

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Ischemia

Infarction

Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Niguarda Hospital
Information provided by:	Niguarda Hospital
ClinicalTrials.gov Identifier:	NCT00257153