OPTical Coherence Tomography IMAging in Patients With Acute myocardiaL Infarction (OPTIMAL)
OPTIMAL
1 other identifier
observational
4,500
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2017
CompletedStudy Start
First participant enrolled
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJune 9, 2021
June 1, 2021
4.1 years
March 15, 2017
June 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major cardiovascular adverse events rate
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 Outcomes (4)
The rate of procedural strategy changes during the primary PCI
baseline
The incidence of procedural complications
baseline
the indience of different plaque characteristic in the setting of STEMI
baseline
Major cardiovascular adverse events rate
2 and 3 year
Study Arms (2)
OCT group
1500 AMI patients with OCT imaging guidance during PCI
CAG group
3000 AMI patients without OCT imaging guidance during PPCI
Eligibility Criteria
Patients with AMI who undergo primary PCI.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harbin Medical Universitylead
- Abbottcollaborator
Study Sites (20)
Beijing An Zhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
Peking Univerisity People'Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Guangdong general hospital
Guangzhou, Guangdong, China
The first affiliated hospital of Guangxi medical university
Nanning, Guangxi, 530021, China
The Second Affiliated Hospital of Hebei Meidical University
Shijiazhuang, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
The first affiliated hospital of Zhengzhou medical university
Zhengzhou, Henan, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The first hospital of Jilin University
Changchun, Jilin, 130000, China
The Second Hospital of Jilin University
Changchun, Jilin, 130000, China
The third hospital of Jilin University
Changchun, Jilin, 130000, China
the second affiliated hospital of Dalian medical university
Dalian, Liaoning, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xian, Shanxi, 710061, China
The General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Related Publications (2)
Wang N, Xu YS, Feng X, Zeng M, Chen X, Yu B, Kou JJ. Stress hyperglycemia ratio and long-term prognosis in patients with acute myocardial infarction undergoing percutaneous coronary intervention: evidence for an J-shaped association. J Geriatr Cardiol. 2025 Dec 28;22(12):981-991. doi: 10.26599/1671-5411.2025.12.001.
PMID: 41477146DERIVEDWang J, Fang C, Zhang S, Li L, Lu J, Wang Y, Wang Y, Yu H, Wei G, Yin Y, Jiang S, Guo J, Lei F, Liu H, Xu M, Ren X, Ma L, Tu Y, Xing L, Hou J, Dai J, Yu B. Systemic and local factors associated with reduced thrombolysis in myocardial infarction flow in ST-segment elevation myocardial infarction patients with plaque erosion detected by intravascular optical coherence tomography. Int J Cardiovasc Imaging. 2021 Feb;37(2):399-409. doi: 10.1007/s10554-020-02021-1. Epub 2020 Sep 28.
PMID: 32989612DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Yu, MD,PhD
The Second Affiliated Hospital of Harbin Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director,Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
March 15, 2017
First Posted
March 21, 2017
Study Start
May 17, 2017
Primary Completion
July 1, 2021
Study Completion
December 1, 2022
Last Updated
June 9, 2021
Record last verified: 2021-06