STEMI Clinical Trial
— Rheo-STEMIOfficial title:
Rheolytic Thrombectomy in Patients With Acute STEMI and Large Thrombus Burden
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Clinical exclusion criteria: 1. STEMI patients receiving fibrinolytic therapy. 2. Cardiogenic shock. 3. 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. 4. Patients refusing to participate in the study. - Angiographic exclusion criteria: 1. Infarct artery reference vessel diameter <2.5 mm on visual assessment. 2. Previously stented infarct artery. 3. TIMI thrombus grade < 4. 4. Inability to identify the infarct artery. - Contraindications to adenosine: 1. Second or third degree atrioventricular block 2. Sick sinus syndrome 3. Systolic blood pressure less than 90 mm Hg 4. Sinus bradycardia (heart rate<40 bpm) 5. Active bronchospastic disease with regular use of inhalers 6. Known hypersensitivity to adenosine - Contraindications to CMR : 1. Cerebral aneurysm clips 2. MRI non compatible cardiac pacemaker 3. Implanted cardioverter-defibrillator 4. Retained transvenous pacemaker and defibrillator leads 5. Electronic implant or device, eg, insulin pump or other infusion pump 6. Cochlear, otologic, or other ear implant 7. Shunt (spinal or intraventricular) 8. Tissue expander (eg, breast) 9. Joint replacement (eg, hip, knee, etc) 10. Any type of prosthesis (eg, eye, penile, etc) 11. Known claustrophobia 12. Body piercing jewelry 13. Known/possible pregnancy or breast feeding. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Aswan Heart Centre - Magdi Yacoub Heart Foundation | Aswan |
Lead Sponsor | Collaborator |
---|---|
Magdi Yacoub Heart Foundation |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | ST segment resolution | According to pre and post- procedure ECG findings. | after 60 minutes of the procedure | No |
Secondary | Corrected TIMI frame count | From the final image of the coronary angiogram. | During the coronary angio to assess flow after the procedure. | No |
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