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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Taizhou First People's Hospital | OTHER |
| Changxing People's Hospital |
To compare the long-term clinical outcomes of IVUS-guided vs angiography-guided PCI in patients with acute STEMI
This study is a prospective, multicenter, randomized controlled trial, led by the second hospital affiliated to zhejiang university school of medicine, A total of 10 hospitals in zhejiang province interventional cardiovascular center to participate in, plan to recruit 200 STEMI patients.
Subjects according to the proportion of 1:1 were randomly allocated to two treatment groups.(Experimental group (IVUS) steering group or control group (imaging) steering group.) Plan 10 centers in 200 men and women aged 18 and older patients, according to the American heart association and the United States The college of cardiology interventional treatment guidelines for the participants.
Each center recruiting number does not exceed 40% of the total plan recruitment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI) | Procedure | Preoperative criminal vascular assessmentï¼› The criminal vascular assessment after surgery |
|
Inclusion Criteria:
-Clinical Inclusion (CI) Criteria: CI. Age > 18 years C2. Onset of STEMI > 30 minutes, but < 12 hours C3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG C4. Willing and able to provide informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Dong | Contact | 13858188861 | gemsangel@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianan Wang | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine at Zhejiang University | Available | Hangzhou | Zhejiang | 310009 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2020 |
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| OTHER |
| Jun 9, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2021 | Jun 9, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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