Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
347 participants
OBSERVATIONAL
2017-01-11
2023-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with STEMI treated medically
Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel) for at least 12 months.
dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel)
Patients who met the inclusion criteria will be treated with dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel).
Interventions
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dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel)
Patients who met the inclusion criteria will be treated with dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel).
Eligibility Criteria
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Inclusion Criteria
* Patients undergo cardiac catheterization for STEMI. STEMI will be defined as continuous chest pain for \>30 minutes, arrival at the hospital within 24 hours from chest pain onset, ST-segment elevation \>0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB).
* Culprit lesion located in a native coronary artery.
* TIMI flow grade 3 and diameter stenosis \< 70% by visual assessment on angiogram or MLA \> 1.6mm2.
* Plaque erosion and rupture defined by OCT.
* Patients able to provide written informed consent.
Exclusion Criteria
* Lesions in LM, ostial LAD or RCA (defined as within 3 mm of the aorto-ostium).
* Long lesions, tortuous lesions and angulated lesions.
* More than 2 vessels with severe lesions.
* Massive residual thrombus after the thrombus aspiration.
* With the history of cardiopulmonary resuscitation (CPR), acute pulmonary edema and cardiac shock on the attacks.
* Life expectancy \< 1 year.
* Contraindication to the contrast media.
* Creatinine level \> 2.0 mg/dL or end-stage kidney disease.
* Serious liver dysfunction.
* Patients with hemodynamic or electrical instability (including shock).
* Any contraindication against the use of ticagrelor.
* Investigator considers the patient is not suitable.
18 Years
75 Years
ALL
No
Sponsors
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Shenzhen Salubris Pharmaceuticals Co., Ltd.
INDUSTRY
Beijing Luhe Hospital
OTHER
The First Hospital of Jilin University
OTHER
China-Japan Union Hospital, Jilin University
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
Harbin Medical University
OTHER
Responsible Party
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Yu Bo
Director
Principal Investigators
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Bo YU, MD, PhD
Role: STUDY_CHAIR
The Second Affiliated Hospital of Harbin Medical University
Locations
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Beijing Luhe Hospital
Beijing, Beijing Municipality, China
Xiamen Cardiovascular Hospital, Xiamen University
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, 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, China
The First Hospital of Jilin University
Changchun, Jilin, 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
Countries
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Other Identifiers
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HMUOCT-EROSIONII
Identifier Type: -
Identifier Source: org_study_id
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