PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation-combined embolic protection and thrombectomy during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomised comparison using the PROXIS™ device

ISRCTN	ISRCTN71104460
DOI	https://doi.org/10.1186/ISRCTN71104460
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	Academic Medical Centre (Netherlands)

Submission date: 23/01/2007
Registration date: 05/03/2007
Last edited: 26/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Joost Haeck
Scientific

Department of Cardiology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Study information

Primary study design	Interventional
Study design	Prospective randomised open trial with blinded evaluation of patient outcomes
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PREPARE
Study objectives	The use of the PROXIS™ combined embolic protection and thrombectomy device during primary percutaneous coronary intervention (PCI) leads to a more rapid resolution of ST-segment elevation, to increased thrombolysis in myocardial infarction (TIMI)-graded coronary flow and myocardial blush, to smaller enzymatic infarct-size and is effective in the reduction of distal embolisation compared to standard primary PCI in acute ST-elevation myocardial infarction (MI).
Ethics approval(s)	Approval received from the local ethics committee (Medisch Ethische Commissie (MEC), Academisch Medisch Centrum, Universiteit van Amsterdam) on the 15th July 2005 (ref: MEC 05/168).
Health condition(s) or problem(s) studied	Myocardial infarction
Intervention	Patients with symptoms of acute MI within the previous six hours, persistent ST-elevation and a coronary anatomy suitable for PROXIS™ are randomly assigned to combined embolic protection and thrombectomy with PROXIS™, or standard PCI. All patients receive: 1. Acetylsalicylic acid (300 mg) 2. Clopidogrel at a starting dose of 600 mg 3. Unfractionated heparin (70 U/kg) Abciximab can be given at any time of the procedure, at the discretion of the operator. PCI of the infarct-related artery is performed by experienced operators, according to standard clinical practice, using standard material such as guide-wires, balloons and stents. Serial electrocardiograms (ECGs) are taken prior to, immediately after, 30 minutes, one hour, three and six hours after the final angiogram during the PCI-procedure. Continuous 12-lead ST-segment monitoring is started as early as possible and is continued for at least six hours after the procedure. The continuous ECG is recorded on a study device through routinely placed leads. The continuous ECGs are analysed at the eECG core lab at Duke Clinical Research Institute under the supervision of M. Krucoff. Angiographic TIMI-graded coronary flow is documented prior to, and immediately after PCI, as well as myocardial blush grade and angiographic signs of distal branch embolisation on the final angiograms after completion of the procedure. Serial creatine kinase myocardial bands (CK-MB) mass, troponin-T, α-hydroxybutyrate dehydrogenase (α-HBDH) and n-terminal prohormone brain natriuretic peptide (NT proBNP) are measured for infarct-size estimation, according to standard clinical procedures. Clinical follow-up is obtained at one and six months after randomisation and left ventricular function is assessed by magnetic resonance imaging (MRI) between six and nine months. Patients are studied on a clinical 1.5 or 3.0 Tesla scanner with a radio frequency receiver coil. Functional imaging: ECG-gated cine steady state free precession (SSFP) magnetic resonance (MR) images are obtained during repeated breath-holds in the three standard long axis views (four-, three- and two-chamber view). Additional short axis slices are acquired covering the entire left ventricle, to examine regional and global left ventricular function. Infarct imaging: During intravenous (i.v.) injection of gadopentetic acid (Gd-DTPA) first-pass perfusion imaging is performed with a saturation-recovery gradient-echo pulse sequence. Delayed contrast-enhanced images are acquired 10 and 30 minutes post-contrast with an inversion-recovery gradient-echo pulse sequence to identify the location and extent of myocardial infarction. The data are obtained with slice locations identical to the functional images. In case of the use of the PROXIS™ combined embolic protection and thrombectomy device, the presence of evacuated material is evaluated by visual assessment and confirmed by pathology. During the study period, baseline data of all not-included patients undergoing primary PCI at our centre are documented.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Acetylsalicylic acid, clopidogrel, abciximab and unfractionated heparin
Primary outcome measure(s)	The primary endpoint of this study is a more than 70% resolution of ST-segment elevation at one hour after PCI, compared to ST-segment elevation immediately prior to PCI.
Key secondary outcome measure(s)	The secondary endpoints are: 1. ECG: the time course of the percentage of ST-segment elevation resolution (as a quantitative parameter) 2. Angiographic: the incidence of angiographic evidence distal embolisation based on TIMI-graded coronary flow, myocardial blush grade and distal branch occlusion 3. Laboratory: the myocardial infarct-size as assessed by serial CK-MB mass, troponin-T, α-HBDH, and NT proBNP, according to standard clinical practice 4. MRI: the difference of infarct size measured by left ventricular ejection fraction (LVEF) and by contrast enhanced MRI-infarct size between six and nine months after PCI, between patients treated by standard PCI and patients treated by PCI combined embolic protection and thrombectomy using the PROXIS™ 5. Clinical: the incidence of death, MI or rehospitalisation for non-ST-segment elevation acute coronary syndrome (nSTE-ACS), repeat PCI of the infarct related artery, CABG and stroke at one, six and 12 months. ECG-evaluation for ST-elevation resolution is performed blinded to the randomisation. The TIMI flow rate, the myocardial blush grade and the presence of distal embolisation is assessed on the final angiograms, made immediately following the primary coronary angioplasty, by two experienced investigators who are blinded to all other data.
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	280
Key inclusion criteria	Consecutive patients with an acute ST-segment elevation MI undergoing primary PCI: 1. Primary PCI within six hours after onset of symptoms of myocardial infarction 2. Electrocardiographic evidence of persistent ST-segment elevation of at least 0.1 mV in two or more contiguous leads at the time of randomisation 3. Proximal obstruction of infarct related coronary artery with TIMI zero to two flow with minimal diameter of 2.5 mm or more 4. The obstruction is amenable to the use of the PROXIS™ as judged by an experienced operator
Key exclusion criteria	1. Younger than 18 years of age 2. Use of a thrombolytic agent within the previous 48 hours 3. Prior coronary artery bypass graft (CABG) 4. Contraindications to the use of a glycoprotein (GP) IIb/IIIa inhibitor 5. Co-existent condition associated with a limited life expectancy
Date of first enrolment	05/12/2005
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

Canada
Netherlands

Study participating centre

Department of Cardiology

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009		Yes	No
Results article	results	01/02/2010		Yes	No