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Acute Myocardial InfarctionOPTIMALNCT03084991

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

An observational study of Acute Myocardial Infarction, run by Harbin Medical University at 20 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
How many people
4,500 participants
Where
20 sitesChina
Study dates
17 May 2017to Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with AMI who undergo primary PCI.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

20 sites in 1 country.

Bo Yu, MD,PhD contact

+86045186605180

yubodr@163.com

Haibo Jia, MD,PhD contact

+8615945685291

20 sites in 1 country

China20 sites, 20 recruiting

  • Beijing An Zhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

    Zening Jin

    Not yet recruiting

  • Peking Univerisity People'Hospital

    Beijing, Beijing Municipality, 100044

    Weimin Wang

    Not yet recruiting

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Lefeng Wang, wlf311@sohu.com

    Not yet recruiting

  • The first hospital of Jilin University

    Changchun, Jilin, 130000

    Yang Zheng

    Not yet recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

    Bin Liu, liubin3333@vip.sina.com

    Not yet recruiting

  • The third hospital of Jilin University

    Changchun, Jilin, 130000

    Ping Yang

    Not yet recruiting

  • the second affiliated hospital of Dalian medical university

    Dalian, Liaoning

    Peng Qu

    Not yet recruiting

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163001

    Hui Li

    Not yet recruiting

  • Guangdong general hospital

    Guangzhou, Guangdong

    Ning Tan

    Not yet recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

    Bo Yu, MD,PhD, 86-045186605180, yubodr@163.com

    Bo Yu, MD,PhD

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Yanqing Wu

    Not yet recruiting

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

    Genshan Ma

    Not yet recruiting

  • The first affiliated hospital of Guangxi medical university

    Nanning, Guangxi, 530021

    Lang Li

    Not yet recruiting

  • The Second Affiliated Hospital of Hebei Meidical University

    Shijiazhuang, Hebei

    Xianghua Fu

    Not yet recruiting

  • The General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

    Shaopeng Xu

    Not yet recruiting

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality

    Chunjie Li

    Not yet recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    Yining Yang

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Qiang Xie

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xian, Shanxi, 710061

    Zuyi Yuan

    Not yet recruiting

  • The first affiliated hospital of Zhengzhou medical university

    Zhengzhou, Henan

    Ling Li

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Keywords
STEMI, NSTEMI
Medical subject headings
ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03084991
Study groupRoleWhat they receive
OCT group1500 AMI patients with OCT imaging guidance during PCI
CAG group3000 AMI patients without OCT imaging guidance during PPCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 1 year

Secondary outcomes (4)

  1. The rate of procedural strategy changes during the primary PCI

    The rate of procedural strategy changes (thrombus aspiration or not, stenting or not, postdilation or not.) during the primary PCI.

    Measured: baseline

  2. The incidence of procedural complications

    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.

    Measured: baseline

  3. the indience of different plaque characteristic in the setting of STEMI

    The incidence of plaque erosion, plaque rupture, calcified nodules, and other uncommon causes in the setting of STEMI.

    Measured: baseline

  4. Major cardiovascular adverse events rate

    The incidence of major adverse cardiovascular events (MACE) at 24 months and 36 months after index procedure.

    Measured: 2 and 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2017
  2. Study start17 May 2017
  3. Primary completionJul 2021 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
4,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03084991
Sponsor's protocol ID
Harbin OCT-Registry
Acronym
OPTIMAL
Status last verified
Jun 2021
First submitted
15 Mar 2017
Last updated
9 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41477146

  • Wang 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.

    PubMed 32989612

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction, run by Harbin Medical University at 20 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bo Yu, MD,PhD (+86045186605180, yubodr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major cardiovascular adverse events rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03084991, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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