Rheolytic Thrombectomy in Patients With Acute STEMI and Large Thrombus Burden

• Register: ClinicalTrials.gov
• Last refreshed on: 23 November 2015
• Main ID: NCT02604394
• Date of registration: 10/11/2015
• Prospective Registration: No
• Primary sponsor: Magdi Yacoub Heart Foundation
• Public title: Rheolytic Thrombectomy in Patients With Acute STEMI and Large Thrombus Burden Rheo-STEMI
• Scientific title: Rheolytic Thrombectomy in Patients With Acute STEMI and Large Thrombus Burden
• Date of first enrolment: November 2015
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02604394
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Egypt

Contacts

• Name: Ahmed M ElGuindy, MD, MRCP

• Name: Ahmed M ElGuindy, MD, MRCP
• Affiliation: Head of Cardiology Dept. at Aswan Heart Centre - Magdi Yacoub Heart Foundation - Aswan, Egypt.

• Name: Ahmed M ElGuindy, MD, MRCP

• Name: David Antoniucci, MD, Interventional Cardiology
• Affiliation: Head of Interventional Cardiology Dept., Careggi Hospital - University of Florence, Italy.

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

STEMI

ST Elevation Myocardial Infarction

Intervention(s)

Procedure: Conventional PCI

Procedure: Rheolytic Thrombectomy

Primary Outcome(s)

Myocardial Salvage Index assesed by CMR [Time Frame: 48 hours after the Intervention and after 3 month of the STEMI.]

Secondary Outcome(s)

Corrected TIMI frame count [Time Frame: During the coronary angio to assess flow after the procedure.]

ST segment resolution [Time Frame: after 60 minutes of the procedure]

Secondary ID(s)

Rheo-STEMI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors