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| Name | Class |
|---|---|
| Shenzhen Salubris Pharmaceuticals Co., Ltd. | INDUSTRY |
| Beijing Luhe Hospital | OTHER |
| The First Hospital of Jilin University | OTHER |
| China-Japan Union Hospital, Jilin University |
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This protocol describes a prospective, multi-center study intended to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis <70%) can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI) with stent implantation. All the patients will be followed by intracoronary OCT and physiological assessment at 1-month and 12-month follow-up.
EROSION (Effective anti-thrombotic therapy without stenting: intravascular optical coherence tomography-based management in plaque erosion) study, a single-center, uncontrolled, prospective, proof-of concept study, showed that for patients with ACS caused by non-obstructive plaque erosion, conservative treatment with anti-thrombotic therapy without stenting may be an option. However, it is unknown whether plaque rupture with large lumen area and non-obstructive stenosis can be treated medically without stenting. EROSION II study is a prospective, multi-center, observational study to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis <70% by visual assessment) can be stabilized and healed by effective antithrombotic treatment without stent implantation. Patients presenting with STEMI within 24 hours from the onset of ischemic symptoms will be included for screening. Thrombus aspiration will be performed in patients with large thrombus burden and TIMI flow grade less than 2 to restore blood flow. OCT will be performed after antegrade blood flow restored to assess the underlying mechanism of culprit lesion including plaque rupture, plaque erosion, calcified nodule, spontaneous coronary artery dissection, and other uncommon reasons. OCT imaging of non-culprit vessels will be performed if feasible. Patients caused by plaque erosion or plaque rupture with minimal lumen area > 1.6mm2 or non-obstructive stenosis (diameter stenosis <70% by visual assessment) will be treated medically only with dual anti-platelet therapy for 12 months after discharge.
Serial OCT examination will be performed at 1-month and 12-month follow-up to assess the healing of original culprit lesion. Physiological assessment (either wire-based FFR or angio-based FFR) will also be performed to assess the hemodynamic function of culprit lesion. The primary endpoint is the reduction of thrombus burden assessed by OCT at 1-month follow-up. Presence of recurrent ischemia symptoms or positive FFR value are the indications for target lesion revascularization. Patients will be followed by phone calls by study coordinators or clinical visit at 1 month, 3 months, 6 months, 9 months and 12 months. Major cardiovascular adverse events (MACE) will be collected in all patients throughout the whole follow-up period. MACE is a composite of cardiac death, recurrent myocardial infarction, stroke, target lesion revascularization, major bleeding and unstable angina-induced rehospitalization.
Patients who do not meet the criteria after OCT imaging will be enrolled in registry cohort.
Blood sample will be obtained from artery sheath or coronary artery by aspiration catheter during the PCI procedure in selected sites. Blood samples will be stored at -80°C for potential biomarker test and multi-omics analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with STEMI treated medically | Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel) for at least 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel) | Drug | Patients who met the inclusion criteria will be treated with dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel). |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of thrombus burden assessed by OCT | The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major cardiovascular adverse events | In patients treated conservatively, the safety objectives are to evaluate the occurrence of any adverse events during 1, 3, 6, 9, 12 months follow up (re-infarction, re-hospitalization due to unstable angina, revascularization by PCI or CABG, cardiac death, stroke, and major bleeding). | 1, 3, 6, 9, 12 months after PCI |
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Inclusion Criteria:
Exclusion Criteria:
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Study population is STEMI patients who undergo primary cardiac catheterization.
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| Name | Affiliation | Role |
|---|---|---|
| Bo YU, MD, PhD | The Second Affiliated Hospital of Harbin Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Luhe Hospital | Beijing | Beijing Municipality | 101100 | China | ||
| Xiamen Cardiovascular Hospital, Xiamen University |
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2020
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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Not provided
| OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Shanxi Cardiovascular Hospital | OTHER |
| Second Hospital of Shanxi Medical University | OTHER |
| Hebei General Hospital | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
| Affiliated Hospital of Jiangsu University | OTHER |
| Xiamen Cardiovascular Hospital, Xiamen University | OTHER |
| Shenzhen Sun Yat-sen Cardiovascular Hospital | OTHER |
| LanZhou University | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Wuhan Asia Heart Hospital | OTHER |
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Blood sample will be obtained from artery sheath or coronary artery by aspiration catheter during the PCI procedure in selected sites, and will be stored at -80°C.
| Major cardiovascular adverse events | compare the difference of clinical outcome in patients with plaque rupture and erosion. | 1 and 12 months after PCI |
| Effective flow area increase | Effective flow area increase | 1 and 12 months after PCI |
| Fractional flow reserve | either wire-based FFR or angio-based FFR | 1 and 12 months after PCI |
| Xiamen |
| Fujian |
| China |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | China |
| Shenzhen Sun Yat-sen Cardiovascular Hospital | Shenzhen | Guangzhou | China |
| Hebei General Hospital | Shijiazhuang | Hebei | China |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150081 | China |
| Wuhan Asia Heart Hospital | Wuhan | Hubei | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| China-Japan Union Hospital of Jilin University | Changchun | Jilin | 130000 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | China |
| Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| Shanxi Cardiovascular Hospital | Taiyuan | Shanxi | China |
| The First Affiliated Hospital of Dalian Medical University | Dalian | Shenyang | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | China |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |