ST Elevation Myocardial Infarction
Conditions
Keywords
STEMI, Intravascular ultrasound, Angiography, Primary percutaneous intervention
Brief summary
To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction.
Detailed description
Intravascular ultrasound (IVUS) has been increasingly used as a guide for percutaneous coronary intervention (PCI) during elective as well as emergent clinical scenario. Recent small number randomized studies, large scale registries as well as meta-analysis have consistently demonstrated advantages of IVUS-guidance over angiography-guide alone with respect to the lower incident of death, myocardial infarction and target vessel revascularization. There are sparse data available on the clinical impact of IVUS-guided PCI in the setting of acute myocardial infarction (AMI) and its use remains a matter of controversy as shown by previous studies. This study is to examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction (STEMI).
Interventions
PROCEDUREIVUS-guided PCI
Performing intravascular ultrasound before or/and after percutaneous intervention
PROCEDUREAngiography-guided PCI
Performing percutaneous intervention without intravascular ultrasound guidance
Sponsors
Ningbo No. 1 Hospital
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Wenzhou Medical University
The First Affiliated Hospital of Xiamen University
Shanghai Chest Hospital
Taizhou Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical inclusion criteria: 1. Age \> 18 years 2. Onset of STEMI \> 30 minutes, but \< 12 hours 3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG 4. Willing and able to provide informed consent * Angiographic inclusion criteria: 1. Having at least one infarct-related coronary artery, of which (1) the Culprit lesion is suitable for stenting (2) the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm (3) the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing 2. No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
Exclusion criteria
* Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac event (MACE) rate | 1 year | Defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR) |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac death rate | 2-3 years |
| Non-cardiac death rate | 2-3 years |
| All death (cardiac and non-cardiovascular) rate | 2-3 years |
| Stent Thrombosis (ST) rate (ARC definite/probable) | 2-3 years |
| MI (Q-wave and non-Q-wave) rat | 2-3 years |
| Target lesion revascularization (TLR) rate | 2-3 years |
| Target lesion failure (TLF) rate | 2-3 years |
| TVR rate | 2-3 years |
| Target vessel failure (TVF) rate | 2-3 years |
| MACE rate | 2-3 years |
Countries
China
Contacts
Primary ContactJun Jiang, MD, PhD
Backup ContactLiang Dong, MD, PhD
Outcome results
None listed