OPTical Coherence Tomography IMAging in Patients With Acute myocardiaL Infarction (OPTIMAL)
- Conditions
- Acute Myocardial Infarction
- Registration Number
- NCT03084991
- Lead Sponsor
- Harbin Medical University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4500
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major cardiovascular adverse events rate 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)
- Secondary Outcome Measures
Name Time Method The rate of procedural strategy changes during the primary PCI baseline The rate of procedural strategy changes (thrombus aspiration or not, stenting or not, postdilation or not.) during the primary PCI.
Major cardiovascular adverse events rate 2 and 3 year The incidence of major adverse cardiovascular events (MACE) at 24 months and 36 months after index procedure.
The incidence of procedural complications 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.
the indience of different plaque characteristic in the setting of STEMI baseline The incidence of plaque erosion, plaque rupture, calcified nodules, and other uncommon causes in the setting of STEMI.
Trial Locations
- Locations (20)
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
the second affiliated hospital of Dalian medical university
🇨🇳Dalian, Liaoning, China
Beijing An Zhen Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking Univerisity People'Hospital
🇨🇳Beijing, Beijing, China
Beijing Chao-Yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Guangdong general hospital
🇨🇳Guangzhou, Guangdong, China
The first affiliated hospital of Guangxi medical university
🇨🇳Nanning, Guangxi, China
The Second Affiliated Hospital of Hebei Meidical University
🇨🇳Shijiazhuang, Hebei, China
Daqing Oilfield General Hospital
🇨🇳Daqing, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The first affiliated hospital of Zhengzhou medical university
🇨🇳Zhengzhou, Henan, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
🇨🇳Xian, Shanxi, China
The first hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The third hospital of Jilin University
🇨🇳Changchun, Jilin, China
Tianjin Chest Hospital
🇨🇳Tianjing, Tianjin, China
The General Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China