OPTical Coherence Tomography IMAging in Patients With Acute myocardiaL Infarction (OPTIMAL)

Harbin Medical University

Status: Unknown

Conditions: Acute Myocardial Infarction

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03084991

Harbin OCT-Registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,500 participants in 2 patient groups

OCT group

Description:

1500 AMI patients with OCT imaging guidance during PCI

CAG group

Description:

3000 AMI patients without OCT imaging guidance during PPCI