Acute Myocardial Infarction
Conditions
Keywords
STEMI, NSTEMI
Brief summary
The purpose of the study is to investigate the clinical outcomes, safety and cost-effectiveness of intravascular OCT imaging in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI). About 4500 patients with acute myocardial infarction (estimated 1500 with OCT guidance and 3000 without OCT guidance during PCI）will be prospectively enrolled in 20 sites in China. The total duration of the study is expected to be 5 years, 2 years for enrolment and 3 years for follow up.
Detailed description
This is a prospective, multi-center, non-randomized, observational registry study of patients with acute myocardial infarction (AMI) that require catheterization. The purpose of this registry is to investigate the clinical outcomes, safety and cost-effectiveness of intravascular OCT imaging in patients with AMI undergoing PCI.The duration of the study is expected to be 5 years, 2 years for enrolment and 3 years for total follow up.The clinical study will be conducted in 20 centers in China.Approximately 4500 subjects (1500 with OCT imaging and 3000 without OCT imaging) will be enrolled in this study.Subjects will be followed up at 1, 3, 6, 12months and every 6 months afterwards up to 5 years. All subjects need to be followed for at least 12 months.
Interventions
None listed
Sponsors
Abbott
Harbin Medical University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients presenting with:a.Symptoms of myocardial ischemia lasting for ≥ 30 minutes.b.Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads, or presumed new left bundle branch block. c. NSTEMI * Referred for primary PCI. * Are able to provide written Informed Consent prior to any study related procedure.
Exclusion criteria
* Patient who is unable to comply with the follow-up schedule. * Left main occlusion * Unable to restore TIMI flow grade III before stenting * Prior coronary artery bypass surgery (CABG) * Cardiogenic shock * Patient who has any medical conditions that in the opinion of the investigator will not be appropriate to participate in the study. * Patient has a life expectancy of less than 6 month due to any condition. * Age ≤ 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major cardiovascular adverse events rate | 1 year | In patients treated conservatively, the safety objectives are to evaluate the occurrence of any adverse events in 1 year (re-infarction, re-hospitalization, revascularization by PCI or CABG, cardiac death, stoke, and major bleeding) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of procedural strategy changes during the primary PCI | baseline | The rate of procedural strategy changes (thrombus aspiration or not, stenting or not, postdilation or not.) during the primary PCI. |
| The incidence of procedural complications | baseline | The incidence of procedural complications including coronary artery dissection, acute occlusion, thrombosis, re-infarction, emergent coronary artery bypass graft, bleeding, no/slow reflow, and death. |
| the indience of different plaque characteristic in the setting of STEMI | baseline | The incidence of plaque erosion, plaque rupture, calcified nodules, and other uncommon causes in the setting of STEMI. |
| Major cardiovascular adverse events rate | 2 and 3 year | The incidence of major adverse cardiovascular events (MACE) at 24 months and 36 months after index procedure. |
Countries
China
Contacts
Primary ContactBo Yu, MD,PhD
Backup ContactHaibo Jia, MD,PhD
Outcome results
None listed