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

Acute Myocardial Infarction Clinical Trial

— OPTIMAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03084991
• Other study ID #: Harbin OCT-Registry
• Status: Recruiting
• Start date: May 17, 2017
• Est. completion date: December 2022

Study information

• Verified date: June 2021
• Source: Harbin Medical University
• Contact: Bo Yu, MD,PhD
• Phone: +86045186605180
• Email: yubodr[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: December 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
China	Beijing An Zhen Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing	Beijing
China	Peking Univerisity People'Hospital	Beijing	Beijing
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	the second affiliated hospital of Dalian medical university	Dalian	Liaoning
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	Guangdong general hospital	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	The first affiliated hospital of Guangxi medical university	Nanning	Guangxi
China	The Second Affiliated Hospital of Hebei Meidical University	Shijiazhuang	Hebei
China	The General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Chest Hospital	Tianjing	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The First Affiliated Hospital of Xi'an Jiao Tong University	Xian	Shanxi
China	The first affiliated hospital of Zhengzhou medical university	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Harbin Medical University	Abbott

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline
Secondary	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.	baseline
Secondary	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.	baseline
Secondary	Major cardiovascular adverse events rate	The incidence of major adverse cardiovascular events (MACE) at 24 months and 36 months after index procedure.	2 and 3 year