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| Name | Class |
|---|---|
| Tasly Pharmaceuticals, Inc. | INDUSTRY |
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This prospective, multicenter, randomized, controlled, open-label clinical study has a target enrollment of 240 subjects. It will explore whether STEMI patients transferred to a PCI center following thrombolytic therapy and expected to have stent implantation might benefit from an alternative treatment strategy and the use of new technologies designed to improve myocardial protection throughout the medical care process.
Eligible patients with STEMI who meet the Inclusion/Exclusion Criteria will receive thrombolytic therapy, and then be transferred to the PCI center for coronary angiography (CAG). Patients having a target vessel with TIMI grade 3 flow as shown by CAG, and and ≥ 50% angiographic stenosis after thrombus aspiration, will be randomized in a 1:1 ratio to either an immediate stenting group or a deferred stenting group. Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
All subjects will be recorded postoperative microcirculation perfusion and ST-segment drop of electrocardiogram and followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information including their general condition, chief complaints or discomforts, details of taking their oral medications, recent relevant test results, and to evaluate the primary endpoint, secondary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate stenting group | Placebo Comparator | Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. |
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| deferred stenting group | Experimental | Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate stenting group(one-step strategy) | Procedure | Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete microvascular perfusion of subepicardial and myocardial tissues-TIMI flow grade 3 | Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%). For the immediate stenting group, the TIMI flow grade will be evaluated immediately after stent implantation. For the deferred stenting group, the TIMI flow grade will be evaluated after the first and second operations. | one minute after the end of the each procedure |
| Complete microvascular perfusion of subepicardial and myocardial tissues-TMP grade 3 | Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%). For the immediate stenting group, the TMP grade will be evaluated immediately after stent implantation. For the deferred stenting group, the TMP grade will be evaluated after the first and second operations. | one minute after the end of the each procedure |
| Complete microvascular perfusion of subepicardial and myocardial tissues-complete ST resolution on an ECG | Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%). All patients will have an 18-lead ECG within 60 minutes after PCI. | within 60 minutes after PCI. |
| Measure | Description | Time Frame |
|---|---|---|
| TIMI flow grade for infarct-related arteries | For the immediate stenting group, the TIMI flow grade will be evaluated immediately after stent implantation. For the deferred stenting group, the TIMI flow grade will be evaluated after the first and second operations. | one minute after the end of the each procedure |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | All deaths will be considered to be cardiac deaths unless a clear non-cardiac cause is identified. Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about all-cause death. | 1, 6, and 12 months |
| New or aggravated heart failure NYHA class IV |
Inclusion Criteria:
Inpatients who meet all of the following criteria can be included in the study:
STEMI criteria:
Exclusion Criteria:
Patients are not eligible for enrollment if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhua Cao, M.D. | Contact | +86 15045643585 | caomuhuayaoyao@163.com | |
| Bo Yu, M.D.,FACC | Contact | +86 13804585601 | yubodr@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 2nd Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150000 | China |
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Eligible patients with STEMI who meet the Inclusion/Exclusion Criteria will receive thrombolytic therapy, and then be transferred to the PCI center for coronary angiography (CAG). Patients having a target vessel with TIMI grade 3 flow as shown by CAG, and and ≥ 50% angiographic stenosis after thrombus aspiration, will be randomized in a 1:1 ratio to either an immediate stenting group or a deferred stenting group. Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
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This study is a prospective, multicenter, randomized, controlled, open-label clinical study.
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|
| deferred stenting group (two-step strategy) | Procedure | Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation. |
|
|
| TIMI myocardial perfusion (TMP) grade for infarct-related arteries |
For the immediate stenting group, the TMPG will be evaluated immediately after stent implantation. For the deferred stenting group, the TMPG will be evaluated after the first and second operations. |
| one minute after the end of the each procedure |
| Measurement of ST resolution on an ECG | All patients will have an 18-lead ECG within 60 minutes after PCI. | 60 minutes after PCI |
| TIMI myocardial blush grade (MBG) for infarct-related arteries | For the immediate stenting group, the MBG will be evaluated immediately after stent implantation. For the deferred stenting group, the MBG will be evaluated after the first and second operations. | one minute after the end of the each procedure |
| Corrected TIMI frame count (cTFC) for infarct-related arteries | For the immediate stenting group, the cTFC will be evaluated immediately after stent implantation. For the deferred stenting group, the cTFC will be evaluated after the first and second operations. | one minute after the end of the each procedure |
| TIMI myocardial perfusion frame count (TMPFC) | All subjects were required to calculate the preoperative and postoperative TMPFC (the delayed group was required to record the TMPFC before and after two operations respectively). | before and after each operation |
| Myocardial infarct size | The infarct area will be determined using semi-automatic contortion in the late short-axis enhanced image and will be expressed as a left ventricular mass percentage (%LV). 2. Five to seven days after the first STEMI intervention (prior to discharge after delayed stent implantation), the myocardial infarct size will be recorded. | five to seven days after the last intervention (prior to discharge) |
| Myocardium salvage index (MSI) |
| five to seven days after the last intervention (prior to discharge) |
Patients with cardiac disease that makes them unable to perform any physical activity without discomfort. Symptoms of heart failure may be present even at rest. If any physical activity is undertaken, discomfort is increased. Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about new or aggravated heart failure NYHA class IV. |
| 1, 6, and 12 months |
| Non-fatal re-infarction or revascularization of any acute infarct-related artery | Myocardial infarction related to restenosis: angiographic restenosis ≥ 50% (complex lesions not found) after one stent implantation or balloon angioplasty procedure, accompanied by an elevation and/or decrease of cTn values in the absence of another occlusion. Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about non-fatal re-infarction or revascularization of any acute infarct-related artery. | 1, 6, and 12 months |
| Cardiogenic shock (1, 6, and 12 months after postoperation) | Cardiogenic shock: systolic blood pressure < 90 mmHg, urine volume < 20 mL/h, clammy skin, cyanosis, tachypnea, and a pulse rate > 100 bpm. Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about cardiogenic shock. | 1, 6, and 12 months |
| Bleeding complications (classified as GUSTO) |
| 1, 6, and 12 months |
| Stroke | Stroke is defined as a sudden onset of focal neurological deficits due to cerebrovascular lesions, which lasts > 24 hours. Stroke is caused by ischemic or hemorrhagic cerebrovascular disorders. Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about stroke. | 1, 6, and 12 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D054058 | Acute Coronary Syndrome |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D003327 | Coronary Disease |
| D014652 | Vascular Diseases |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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