ST-elevation myocardial infarction
Conditions
Interventions
Thrombus Aspiration Group:Thrombus aspiration+PCI
Intracoronary thrombolysis:Intracoronary thrombolysis+PCI
Sponsors
Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old (including critical value), gender is not limited; 2. Acute ST-segment elevation myocardial infarction was diagnosed, and the following two conditions were met: (1) Ischemic chest pain lasting =30 min; (2) ECG indicated ST segment elevation = 0.1mV in 2 or more limb leads, and/or ST segment elevation = 0.2mV in 2 or more adjacent chest leads; 3. Onset of symptoms =12 hours; 4. Coronary angiography showed that the offender's blood vessel was located in the main branch or its main branch of the coronary artery and met the criteria of high thrombotic load, that is, TIMI thrombotic classification (TTG) =4. The criteria for TTG were as follows: Grade 0, no thrombus shadow was seen under angiography; Grade 1: Suspected thrombus, which was manifested as blurred lumen development, cloud shadow, irregular lesion contour or smooth crescent image of protruding lumen in completely occluded area indicating but unable to confirm thrombus; Grade 2: definite presence of thrombus, linear size =1/2 vessel diameter; At grade 3, thrombus is clearly present, and the linear size is 1/2 to 2 times the diameter of the blood vessel; Grade 4: definite presence of thrombus, linear size =2 times the vessel diameter; Stage 5, thrombosis leading to complete occlusion. Note: For patients with complete thrombotic occlusion, thrombus grading is performed after the passage (or dilation) of the guidewire or balloon. 5. The patient gave informed consent, voluntarily participated in the clinical study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Unprotected left main disease; 2. Hemodynamic instability; 3. History of recurrent myocardial infarction or coronary artery bypass grafting; 4. Aortic dissection is clearly, highly suspected, or cannot be ruled out; 5. Patients who have undergone intravenous thrombolysis; 6. Severe calcification, angulation or distortion of coronary arteries, and it is expected that the dual lumen microcatheter or aspiration catheter cannot pass through the target lesion; 7. Previous history of intracranial hemorrhage or ischemic stroke within 3 months; 8. Active bleeding or bleeding factors (including menstruation); 9. Severe trauma or major surgery within 3 weeks or bleeding in areas that cannot be compressed; 10. Severe or poorly controlled hypertension (SBP>180mmHg and/or DBP>110mmHg); 11. Known allergy to any drugs that may be present in the study; 12. Women who are pregnant, breastfeeding or at risk of becoming pregnant; 13. Complicated with severe lung disease, liver and kidney insufficiency; 14. Patients with malignant tumors or expected survival time < 6 months; 15. Long-term use of anticoagulant drugs (such as warfarin, rivaroxaban, etc.); 16. Contraindicated cardiac magnetic resonance examination; 17. The patient also participated in other clinical studies; 18. Subjects deemed unsuitable for inclusion in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of myocardial infarction in left ventricular area measured by cardiac magnetic resonance examination 5-7 days after PCI (%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Microcirculation obstruction as a percentage of myocardial mass (MVO%) and incidence of intra myocardial hemorrhage (IMH) were measured by cardiac magnetic resonance;Proportion of patients with complete ST segment regression in ECG 2h after PCI (%) (the sum of ST segment elevation in myocardial infarct-related leads was measured, with TP segment as the equipotential line; Complete pullback is defined as a pullback =70%);Proportion of patients with slow reflow/no reflow during PCI (slow reflow was defined as TIMI grade 2; No reflow is defined as TIMI level 0 to 1;TIMI frame count (cTFC) after PCI (30 frames per second for image acquisition);Proportion of patients with myocardial blush grade (MBG) Grade 3 after PCI (immediately after PCI);Peak value of cTnT and CK-MB after PCI (12h, 18h, 24h blood collection);Echocardiography (LVDD, LVEF) at 48h and 180-day follow-up after PCI;Incidence of MACEs events (cardiac death, nonfatal myocardial infarction, stent thrombosis, target vessel revascularization, re-hospitalization due to heart failure, stroke) within 180 days after PCI; | — |
Countries
China
Contacts
Public ContactLIkun Ma
Anhui Provincial Hospital
Outcome results
None listed