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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

4500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-17

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myocardial Infarction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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OCT group

1500 AMI patients with OCT imaging guidance during PCI

No interventions assigned to this group

CAG group

3000 AMI patients without OCT imaging guidance during PPCI

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Yu Bo

Director,Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Yu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Harbin Medical University

Locations

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