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To evaluate the effect of optimized thrombus aspiration on myocardial perfusion in patients with STEMI undergoing primary PCI in a randomized, parallel controlled clinical trial

To evaluate the effect of optimized thrombus aspiration on myocardial perfusion in patients with STEMI undergoing primary PCI in a randomized, parallel controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073410
Enrollment
Unknown
Registered
2023-07-10
Start date
2020-12-14
Completion date
Unknown
Last updated
2023-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ST-segment elevation myocardial infarction

Interventions

the control group(groupA):In the control group, PTCA was performed before thrombus aspiration after emergency coronary angiography guide wire passage,Then, primary PCI was performed,thrombus aspiratio
the experimental group(groupC):thrombus aspiration was performed directly after the emergency coronary angiography guide wire was passed,primary PCI was performed after thrombus aspiration was complet
the control group(groupB):aspiration after emergency coronary angiography guide wire passage,Then, primary PCI was performed,thrombus aspiration was performed more than 4 times.
the experimental group(groupD):thrombus aspiration was performed directly after the emergency coronary angiography guide wire was passed,primary PCI was performed after thrombus aspiration was complet

Sponsors

Bengang General Hospital of China Resources Medical Group
Lead Sponsor

Eligibility

Sex/Gender
All
Age
34 Years to 86 Years

Inclusion criteria

Inclusion criteria: (1)Patients with acute ST-segment elevation myocardial infarction within 12 hours of onset according to the international common diagnostic criteria were enrolled.(2)Coronary angiography showed 100% occlusion of IRA,vessel diameter=2.Omm,no obvious tortuosity and calcification.(3)There was no contraindication of antiplatelet and anticoagulant therapy.(4)With a state of high thrombus burden should be aspirated. The state of high thrombus burden:Coronary angiography showed long thrombus more than three times the diameter of the reference vessel;floating thrombus at the proximal end of the occluded vessel;the proximal end of the occluded vessel had >5 mm long strip thrombus;sudden complete occlusion of the proximal vessel without tapering;coronary artery occlusion-related vessels>4.0mm;contrast agent was retained distal to the occluded vessel.

Exclusion criteria

Exclusion criteria: (1) patients had undergone rescue PCI with intravenous thrombolysis; (2) history of intracranial hemorrhage; (3) ischemic stroke within 3 months; (4) suspected aortic dissection; (5) active bleeding or bleeding factors; (6) severe head and face injury within 3 months; (7) severe or poorly controlled hypertension; (8) severe trauma or major surgery or bleeding from vessels that could not be compressed within 3 weeks; (9) patients with malignant tumors; (10) complicated with severe liver and kidney dysfunction; (11) pregnant, lactating or at risk of becoming pregnant; (12)known allergies or contraindications to study drugs or contrast media; (13) patients had participated in other clinical trials at the same time; (14) patients after coronary artery bypass grafting; (15) Coronary angiography showed TIMI grade 3 blood flow in the culprit vessel without obvious signs of thrombosis. (16) patients with acute STEMI more than 12 hours; (17) patients with acute non-STEMI;(18) The lesion was located in the left main coronary artery, the anterior trigeminal artery, the vessel was tortuous and calcified, the lesion was diffuse,and multiple stents were implanted more than 3 pieces;(19)blood pressure=90/60mmHg;shock;Severe heart failure.

Design outcomes

Primary

MeasureTime frame
The classification of thrombi extracted;the TIMI flow grade;the incidence of no-reflow;the incidence of slow flow;cTFC;TPI;CK-MB;NT-proBNP;LVEF;The incidence of bleeding complications;The incidence of stroke events;The incidence of major cardiovascular events;

Secondary

MeasureTime frame
ST segment resolution of ECG;

Countries

China

Contacts

Public ContactBoning Xu

Bengang General Hospital of China Resources Medical Group

xbn1963@163.com+86 180 4144 0258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026