Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction (FISSTEMI)-- A Prospective Randomized Trial of Stent Implantation Strategy After Thrombolytic Therapy

Conditions
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Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Heart Diseases, Syndrome Heart Disease, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Coronary Disease, Vascular Diseases

Intervention / Treatment
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* Procedure: immediate stenting group(one-step strategy)
* Procedure: deferred stenting group (two-step strategy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients who meet all of the following criteria can be included in the study: Age: 18-75 years old; A confirmed diagnosis of STEMI with symptom onset within 12 h; STEMI criteria: Patient has a history of chest pain/discomfort; ST elevation ≥ 0.1 mV in at least two contiguous leads of an ECG on admission (> 30 minutes; ≥ 0.2 mV required for V2 and V3 ) or the development of new left bundle branch block (LBBB); an increase in cardiac biomarkers (troponin, CK-MB) above the 99th percentile of the laboratory upper reference limit; 3. Time from FMC to wire crossing estimated to be > 120 min; 4. Has a target vessel with TIMI grade 3 flow shown as by CAG and ≥ 50% angiographic stenosis after thrombus aspiration; 5. Has culprit lesions identified as primary lesions; 6. Signed the written informed consent form. Exclusion Criteria: Patients are not eligible for enrollment if they meet any of the following criteria: A contraindication to thrombolysis; An estimated survival time ≤ 12 months; Known heart failure of Killip class III or above, or mechanical complications such as heart rupture; Known to be participating in any other clinical trial; Pregnant or lactating women, or women experiencing their menstrual period; Weight < 40 Kg or > 125 Kg; Known allergies to drugs that are required during the study such as contrast agents, antiplatelet drugs, and anticoagulants; A target vessel with TIMI grade 0-2 flow as revealed by the initial CAG; Having lesions located in the LMCA or root of the LAD, or with severe multiple vessel disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: immediate stenting group<br>Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. | Procedure: immediate stenting group(one-step strategy)<br>* Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.<br>* Other names: Immediate Angioplasty;|
| Experimental: deferred stenting group<br>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. | Procedure: deferred stenting group (two-step strategy)<br>* 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.<br>* Other names: Delayed angioplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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) | MSI refers to the ratio of rescue myocardium to AAR, which is a sensitive method to evaluate the effect of treatment. Five to seven days after the first STEMI intervention (prior to discharge after delayed stent implantation), the MSI will be recorded. | five to seven days after the last intervention (prior to discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST Elevation Myocardial Infarction, Microcirculatory dysfunction, Percutaneous coronary intervention, fibrinolysis