Clinical trial NCT03084991: OPTical Coherence Tomography IMAging in Patients With Acute myocardiaL Infarction (OPTIMAL)
Official title: OPTical Coherence Tomography IMAging in Patients With Acute myocardiaL Infarction During Primary PCI (OPTIMAL)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Keywords: STEMI
NSTEMI
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2017-03-21
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with AMI who undergo primary PCI.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major cardiovascular adverse events rate
timeFrame: 1 year
Secondary outcomes:
measure: The rate of procedural strategy changes during the primary PCI
timeFrame: baseline
measure: The incidence of procedural complications
timeFrame: baseline
measure: the indience of different plaque characteristic in the setting of STEMI
timeFrame: baseline
measure: Major cardiovascular adverse events rate
timeFrame: 2 and 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing An Zhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking Univerisity People'Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong general hospital
state: Guangdong
city: Nanning
country: China
facility: The first affiliated hospital of Guangxi medical university
state: Guangxi
city: Shijiazhuang
country: China
facility: The Second Affiliated Hospital of Hebei Meidical University
state: Hebei
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou medical university
state: Henan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The third hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: the second affiliated hospital of Dalian medical university
state: Liaoning
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shanxi
city: Tianjing
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: The General Hospital of Tianjin Medical University
state: Tianjin
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.