Rheolytic Thrombectomy in Patients With Acute STEMI and Large Thrombus Burden
Rheo-STEMI
1 other identifier
interventional
200
1 country
1
Brief Summary
Coronary obstruction by an occlusive thrombus complicating a ruptured or eroded atherosclerotic plaque is the most frequent pathologic substrate of acute myocardial infarction (AMI). Timely restoration of perfusion and thereby myocardial salvage is the single most important objective in the management of patients with ST segment-elevation myocardial infarction (STEMI). To address these uncertainties, our study aims to evaluate the role of RT in patients who are most likely to benefit from it (thrombus grade 4 and 5) using a sensitive, quantitative, and reproducible parameter; CMR-derived myocardial salvage. also, to determine whether Rheolytic Thrombectomy (RT) before conventional PCI to the culprit vessel as compared to conventional PCI (with or without MTA) results in improved myocardial salvage; and to identify clinical and angiographic determinants of any difference observed between both treatment groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 10, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 17, 2015
November 1, 2015
1.9 years
November 10, 2015
November 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial Salvage Index assesed by CMR
Myocardial salvage index (MSI) will be determined as the difference between the area at risk and the total infarct area divided by the area at risk.
48 hours after the Intervention and after 3 month of the STEMI.
Secondary Outcomes (2)
ST segment resolution
after 60 minutes of the procedure
Corrected TIMI frame count
During the coronary angio to assess flow after the procedure.
Study Arms (2)
Rheolytic Thrombectomy with PCI
ACTIVE COMPARATORRheolytic Thrombectomy (RT) will be performed with the The AngioJet rheolytic thrombectomy system (Medrad Interventional/Possis, Minneapolis, Minnesota). The single-pass antrograde thrombectomy technique will be used.
Conventional PCI
SHAM COMPARATORIn patients in the conventional PCI group, antegrade flow in the culprit vessel will be established with conventional PCI with preference of direct stenting and use of manual thrombus aspiration when deemed necessary by the operator.
Interventions
RT will be performed with the The AngioJet rheolytic thrombectomy system (Medrad Interventional/Possis, Minneapolis, Minnesota). The RT system includes three units: disposable catheter, disposable pump set and a reusable drive unit: 1. The single-use catheter has two lumens; one allows for the in-flow of high velocity saline jets through the catheter tip, and the other allows for the evacuation of thrombotic debris and passage of a guidewire. 2. The disposable pump connects to a bag of heparinized saline. 3. The drive unit pumps pressurized heparinized saline at 10,000 psi at the tip of the catheter,
In patients in the conventional PCI group, antegrade flow in the culprit vessel will be established with conventional PCI with preference of direct stenting and use of manual thrombus aspiration when deemed necessary by the operator.
Eligibility Criteria
You may qualify if:
- STEMI with time from symptom onset of \<12 hours duration.
- STEMI with time from symptom onset \< 24 hours, in the presence of ongoing ischaemia, life-threatening arrhythmias or if pain and ECG changes have been stuttering.
You may not qualify if:
- STEMI patients receiving fibrinolytic therapy.
- Cardiogenic shock.
- Patients with clinical, hemodynamic, or electrical instability as well as those judged to be critically ill or when there is need to minimize the procedure length to the shortest possible time.
- Patients refusing to participate in the study.
- Infarct artery reference vessel diameter \<2.5 mm on visual assessment.
- Previously stented infarct artery.
- TIMI thrombus grade \< 4.
- Inability to identify the infarct artery.
- Contraindications to adenosine:
- Second or third degree atrioventricular block
- Sick sinus syndrome
- Systolic blood pressure less than 90 mm Hg
- Sinus bradycardia (heart rate\<40 bpm)
- Active bronchospastic disease with regular use of inhalers
- Known hypersensitivity to adenosine
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aswan Heart Centre - Magdi Yacoub Heart Foundation
Aswān, Aswan Governorate, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Antoniucci, MD, Interventional Cardiology
Head of Interventional Cardiology Dept., Careggi Hospital - University of Florence, Italy.
- PRINCIPAL INVESTIGATOR
Ahmed M ElGuindy, MD, MRCP
Head of Cardiology Dept. at Aswan Heart Centre - Magdi Yacoub Heart Foundation - Aswan, Egypt.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2015
First Posted
November 13, 2015
Study Start
November 1, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
November 17, 2015
Record last verified: 2015-11