Optical Coherence Tomography Examination in Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

— OCTAMI  

Official title:

Pre-intervention and Post-intervention Optical Coherence Tomography Examination for Culprit Lesion in Patients With ST-segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03593928
• Other study ID #: 2018-0710
• Status: Recruiting
• Start date: March 29, 2017
• Est. completion date: April 29, 2020

Study information

• Verified date: May 2019
• Source: China National Center for Cardiovascular Diseases
• Contact: Hongbing Yan, MD
• Phone: 008601088322281
• Email: bcc_ami[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Different plaque morphology may have an important effect on the prognosis of acute myocardial infarction (AMI), as recent studies show that patients with plaque rupture have a significantly higher risk of cardiac events compared with those with plaque erosion. The primary purpose of this study is to find risk factors and biomarkers for different culprit lesion morphology to perform accurate risk stratification and determine an appropriate treatment strategy for patients with AMI.

Description:

Acute myocardial infarction (AMI), which results from coronary artery occlusion due to thrombosis, remains the leading cause of death and disability worldwide. Pathological studies have demonstrated that plaque rupture accompanied by subsequent thrombus formation is the main mechanism responsible for AMI, accounting for approximately two thirds of cases; the remaining approximately one third of cases are the result of plaque erosion. Moreover, previous studies showed that the risk of cardiovascular events is significantly higher in patients with plaque rupture compared to those with plaque erosion. The EROSION study suggested that in patients with acute coronary syndrome presenting with plaque erosion, conservative treatment with anti-thrombotic therapy may be a reasonable option instead of stents implantation. Therefore, it is important to differentiate between the culprit morphologies in order to perform an accurate risk stratification and determine a personalized treatment strategy with the goal to improve the prognosis of patients with AMI.

Optical coherence tomography (OCT), a newly developed high resolution near infrared light-based intravascular imaging modality, can visualize the microstructure of atherosclerotic plaques such as the fibrotic cap, lipid pool, thrombi, and so on, and has been considered as the golden standard for differentiating plaque morphology in vivo.

In this study, we aimed to find risk factors and biomarkers for culprit lesion morphology as assessed by OCT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 29, 2020
• Est. primary completion date: March 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with ST-segment elevation myocardial infarction (defined as continuous chest pain lasted >30 min, ST-segment elevation >0.1 mV in at least two contiguous leads or new left bundle-branch block on the 18-lead electrocardiogram (ECG), and an elevated troponin I level)

• Age =18 years

• Provide written informed consent

Exclusion Criteria:

• Cardiac shock

• History of coronary artery bypass graft

• Left main diseases, extremely tortuous or heavily calcified vessels, or chronic total occlusion

• Inability to obtain Thrombolysis in myocardial infarction flow grade = 2

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Optical Coherence Tomography
• ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	culprit lesion morphology as assessed by OCT	plaque rupture, plaque erosion or calcified nodule	1 day (pre-intervention OCT examination of culprit lesion)