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NCT07687576
Comparative Evaluation of Sustained meChanical AsPiration Thrombectomy and no Thrombus Modification for Pre-stent Thrombus bUrden Reduction in Patients With Acute Myocardial Infarction Study: the CAPTURE AMI Study
Conditions: STEMI - ST Elevation Myocardial Infarction
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 60
Sponsor: Oxford University Hospitals NHS Trust
Location: Oxford Heart Centre - John Radcliffe Hospital Oxford Oxfordshire
Summary
The CAPTURE AMI trial is an investigator-initiated, single-centre, two-arm, randomised controlled trial. Patients aged ≥ 18 years who present with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) will be enrolled after angiographic evidence of a high thrombus burden (TIMI thrombus grade ≥ 4) and meeting the inclusion criteria laid out in section 9.2 will be 1:1 randomised to receive either standalone PCI (Arm 1) or adjunct sustained mechanical thrombectomy + PCI (Arm 2).
The CAPTURE AMI study will enrol specifically patients with:
A. Evidence of high thrombus burden on coronary angiography (TIMI thrombus grade ≥ 4) B. Culprit in an artery with a diameter of 3.0 mm or more. The trial is designed to evaluate the efficacy of sustained mechanical thrombectomy versus standalone PCI in patients with a large thrombus burden assessed angiographically, with a pre-stent thrombus burden (%) as the primary imaging endpoint.
Eligibility Criteria
Inclusion Criteria:
* Primary PCI patient with ST elevation myocardial infarction
* Angiographic criteria:
* TIMI 0/1 flow at presentation
* Angiographic thrombus score ≥ 4
* Vessel diameter at site of occlusion ≥ 3.0mm (determined by coronary angiography)
Exclusion Criteria:
* Female participant who is pregnant or lactating
* Unconscious at presentation
* Late STEMI presentation (symptoms onset to wire time \> 12 h)
* Clinically/haemodynamically unstable patients
* Known diagnosis of severe renal disease (CKD stage 4-5)
* Suspected spontaneous coronary artery dissection
* Previous CABG
* Previous history on STEMI in the same culprit territory
* Known moderate-severe anaemia (Hb \< 9)
Source: ClinicalTrials.gov (NCT07687576). StuddyBuddy aggregates publicly available trial information.