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Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients (PATA-STEMI)

Primary Purpose

Myocardial Infarction

Status

Unknown status

Phase

Phase 3

Locations

Serbia

Study Type

Interventional

Intervention

Eliminate aspiration catheter

Conventional primary angioplasty

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Acute myocardial infarction, Manual thrombus aspiration, Coronary physiology

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All consecutive patients with STEMI
chest pain onset ≤12h, or >12 h with persistent ST-segment elevation
hemodynamically stable patients

Exclusion Criteria:

patients without diagnosis of STEMI (pericarditis, for example)
no written informed consent obtained
prior Q or non-Q MI
prior resuscitation
prior thrombolysis
prior surgical myocardial revascularisation
life expectancy <6 months
periprocedural death

Sites / Locations

Clinical center of SerbiaRecruiting
Clinical Center of SerbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eliminate

Conventional primary angioplasty

Arm Description

Eliminate aspiration catheter

Patients treated with conventional primary angioplasty

Outcomes

Primary Outcome Measures

IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group

IMR will be measured after final balloon inflation or stent implantation, an expected average of 45 minutes after sheath insertion

Secondary Outcome Measures

Resolution of ST-segment elevation

ST-segment resolution ≥70% at 60 minutes after guiding catheter removal

myocardial blush grade (0-3)

myocardial blush grade will be assessed after IMR measurements, following the final balloon inflation or stent implantation, an expected average of 55 minutes after sheath insertion

infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB))

infarct size will be determined based on peak enzyme release (Troponin, CK-MB) during in-hospital stay, an expected average of 5 days

indices of left ventricle remodeling on Echocardiography

left ventricle remodeling will be assessed on Echocardiography within 24 hours and at 4 months after primary PCI

infarct size determined by SPECT

infarct size will be determined by SPECT within 7-14 days and at 4 months after primary PCI

Full Information

NCT ID

NCT01824641

First Posted

March 22, 2013

Last Updated

April 2, 2013

Sponsor

Clinical Centre of Serbia

Collaborators

Center of nuclear medicine, Institute for histology

1. Study Identification

Unique Protocol Identification Number

NCT01824641

Brief Title

Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients

Acronym

PATA-STEMI

Official Title

The Randomized Physiologic Assessment of Thrombus Aspiration in Patients With Acute ST-segment Elevation Myocardial Infarction Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

May 2013 (Anticipated)

Study Completion Date

November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Clinical Centre of Serbia

Collaborators

Center of nuclear medicine, Institute for histology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus aspiration compared to conventional PCI group.

Detailed Description

Background and Objective Routine thrombus aspiration is superior to conventional primary PCI in terms of improved myocardial perfusion in STEMI patients. However, myocardial perfusion after thrombus aspiration has not been evaluated by a quantitative, invasive method. Investigators intend to determine whether thrombus aspiration of the infarct-related artery increases myocardial perfusion, as measured by IMR, compared to conventional primary PCI. Study design PATA-STEMI is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first STEMI. Patients are randomly assigned, before coronary angiography, to thrombus aspiration using the 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary PCI. The IMR will be determined in infarct-related artery and non-infarct-related arteries without critical stenosis to measure microcirculatory resistance. The primary endpoint is defined as IMR in infarct-related artery in thrombus aspiration compared to conventional PCI group. Secondary end points are myocardial perfusion grade and resolution of ST-segment elevation, infarct size and left ventricle remodeling, as assessed by echocardiographic indices. Transthoracic echocardiography will be conducted within 24 hours and at 4 months after the primary PCI. Implications: If manual thrombus aspiration reduces microcirculatory resistance, indicating improved myocardial perfusion, as compared to conventional PCI, it might become the preferred strategy in patients with STEMI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

Acute myocardial infarction, Manual thrombus aspiration, Coronary physiology

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Eliminate

Arm Type

Experimental

Arm Description

Eliminate aspiration catheter

Arm Title

Conventional primary angioplasty

Arm Type

Active Comparator

Arm Description

Patients treated with conventional primary angioplasty

Intervention Type

Device

Intervention Name(s)

Eliminate aspiration catheter

Intervention Description

Eliminate aspiration catheter

Intervention Type

Procedure

Intervention Name(s)

Conventional primary angioplasty

Intervention Description

Primary angioplasty without thrombus aspiration

Primary Outcome Measure Information:

Title

IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group

Description

IMR will be measured after final balloon inflation or stent implantation, an expected average of 45 minutes after sheath insertion

Time Frame

At the end of the primary PCI , an expected average of 45 minutes after sheath insertion

Secondary Outcome Measure Information:

Title

Resolution of ST-segment elevation

Description

ST-segment resolution ≥70% at 60 minutes after guiding catheter removal

Time Frame

at 60 minutes after guiding catheter removal

Title

myocardial blush grade (0-3)

Description

myocardial blush grade will be assessed after IMR measurements, following the final balloon inflation or stent implantation, an expected average of 55 minutes after sheath insertion

Time Frame

at final angiogram, an expected average of 55 minutes after sheath insertion

Title

infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB))

Description

infarct size will be determined based on peak enzyme release (Troponin, CK-MB) during in-hospital stay, an expected average of 5 days

Time Frame

in hospital course after primary PCI, an expected average of 5 days

Title

indices of left ventricle remodeling on Echocardiography

Description

left ventricle remodeling will be assessed on Echocardiography within 24 hours and at 4 months after primary PCI

Time Frame

within 24 hours and at 4 months after primary PCI

Title

infarct size determined by SPECT

Description

infarct size will be determined by SPECT within 7-14 days and at 4 months after primary PCI

Time Frame

within 7-14 days and at 4 months after primary PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All consecutive patients with STEMI chest pain onset ≤12h, or >12 h with persistent ST-segment elevation hemodynamically stable patients Exclusion Criteria: patients without diagnosis of STEMI (pericarditis, for example) no written informed consent obtained prior Q or non-Q MI prior resuscitation prior thrombolysis prior surgical myocardial revascularisation life expectancy <6 months periprocedural death

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dejan Milasinovic, MD

Phone

+381113613653

dejan_milasinovic@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Goran Stankovic, MD, PhD

Phone

+381113615433

gorastan@sbb.rs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dejan Orlic, MD

Organizational Affiliation

Clinical Center of Serbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical center of Serbia

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Milorad Tesic, MD

Phone

+381113615433

misa.tesic@gmail.com

First Name & Middle Initial & Last Name & Degree

Miodrag Ostojic, Prof

First Name & Middle Initial & Last Name & Degree

Branko Beleslin, Prof

First Name & Middle Initial & Last Name & Degree

Goran Stankovic, Prof

First Name & Middle Initial & Last Name & Degree

Sinisa Stojkovic, Professor

First Name & Middle Initial & Last Name & Degree

Vladan Vukcevic, Professor

First Name & Middle Initial & Last Name & Degree

Milica Borovic, Professor

First Name & Middle Initial & Last Name & Degree

Dragana Sobic-Saranovic, Professor

First Name & Middle Initial & Last Name & Degree

Milorad Tesic, MD

First Name & Middle Initial & Last Name & Degree

Dejan Milasinovic, MD

First Name & Middle Initial & Last Name & Degree

Milan Dobric, MD

First Name & Middle Initial & Last Name & Degree

Zlatko Mehmedbegovic, MD

First Name & Middle Initial & Last Name & Degree

Milan Nedeljkovic, Professor

First Name & Middle Initial & Last Name & Degree

Milorad Zivkovic, MD

First Name & Middle Initial & Last Name & Degree

Vladimir Dedovic, MD

Facility Name

Clinical Center of Serbia

City

Belgrade

Country

Serbia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dejan Orlic

Phone

+381113615433

First Name & Middle Initial & Last Name & Degree

Dejan Orlic, MD

12. IPD Sharing Statement

Learn more about this trial

Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients

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