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

June 6, 2021 updated by: Yu Bo, Harbin Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bo Yu, MD,PhD
  • Phone Number: +86045186605180
  • Email: yubodr@163.com

Study Contact Backup

  • Name: Haibo Jia, MD,PhD
  • Phone Number: +8615945685291

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Not yet recruiting
        • Beijing An Zhen Hospital, Capital Medical University
        • Contact:
          • Zening Jin
      • Beijing, Beijing, China, 100044
        • Not yet recruiting
        • Peking Univerisity People'Hospital
        • Contact:
          • Weimin Wang
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Chao-Yang Hospital, Capital Medical University
        • Contact:
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Qiang Xie
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangdong General Hospital
        • Contact:
          • Ning Tan
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Lang Li
    • Hebei
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Hebei Meidical University
        • Contact:
          • Xianghua Fu
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163001
        • Not yet recruiting
        • Daqing Oilfield General Hospital
        • Contact:
          • Hui Li
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Principal Investigator:
          • Bo Yu, MD,PhD
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • The first affiliated hospital of Zhengzhou medical university
        • Contact:
          • Ling Li
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Not yet recruiting
        • Zhongda Hospital Southeast University
        • Contact:
          • Genshan Ma
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Yanqing Wu
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Yang Zheng
      • Changchun, Jilin, China, 130000
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • The Third Hospital of Jilin University
        • Contact:
          • Ping Yang
    • Liaoning
      • Dalian, Liaoning, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:
          • Peng Qu
    • Shanxi
      • Xian, Shanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
          • Zuyi Yuan
    • Tianjin
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • The General Hospital of Tianjin Medical University
        • Contact:
          • Shaopeng Xu
      • Tianjing, Tianjin, China
        • Not yet recruiting
        • Tianjin Chest Hospital
        • Contact:
          • Chunjie Li
    • Xinjiang
      • Urumqi, Xinjiang, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Yining Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with AMI who undergo primary PCI.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
OCT group
1500 AMI patients with OCT imaging guidance during PCI
CAG group
3000 AMI patients without OCT imaging guidance during PPCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major cardiovascular adverse events rate
Time Frame: 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)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of procedural strategy changes during the primary PCI
Time Frame: baseline
The rate of procedural strategy changes (thrombus aspiration or not, stenting or not, postdilation or not.) during the primary PCI.
baseline
The incidence of procedural complications
Time Frame: 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.
baseline
the indience of different plaque characteristic in the setting of STEMI
Time Frame: baseline
The incidence of plaque erosion, plaque rupture, calcified nodules, and other uncommon causes in the setting of STEMI.
baseline
Major cardiovascular adverse events rate
Time Frame: 2 and 3 year
The incidence of major adverse cardiovascular events (MACE) at 24 months and 36 months after index procedure.
2 and 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harbin Medical University

Collaborators

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2017

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 6, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Harbin OCT-Registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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