Randomized Controlled Trial of Optical Coherence Tomography Versus Angiography for Culprit Lesion Revascularization in Patients With Acute Myocardial Infarction

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of the study is to compare clinical outcomes between optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Subject must be at least 19 years of age

• Acute ST-segment elevation myocardial infarction (STEMI)

• \*STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block1

• Primary percutaneous coronary intervention (PCI) in \< 12 h after the onset of symptoms for STEMI patients

• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Locations
Other Locations
Republic of Korea
Dong-A University College of Medicine
RECRUITING
Busan
Kosin University Gospel Hospital
RECRUITING
Busan
Daegu Catholic University Medical Center
RECRUITING
Daegu
Kyungpook National University Hospital
RECRUITING
Daegu
Yeungnam University Medical Center
RECRUITING
Daegu
Chonnam National University
RECRUITING
Gwangju
Wonkwang University Hospital
RECRUITING
Iksan
International St. Mary's Hospital
RECRUITING
Incheon
Jeju National University Hospital
RECRUITING
Jeju City
Jeonbuk National University Hospital
RECRUITING
Jeonju
Gyeongsang National University Hospital
RECRUITING
Jinju
Chung-Ang University Hospital
RECRUITING
Seoul
Ewha Womans University Mokdong Hospital
RECRUITING
Seoul
Ewha Womans University Seoul Hospital
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
St. Carollo Hospital
RECRUITING
Suncheon
Uijeongbu St Mary's Hospital
RECRUITING
Uijeongbu-si
Ulsan University Hospital
RECRUITING
Ulsan
Contact Information
Primary
Seung Hun Lee, MD, PhD
lsh8602@naver.com
82-2-220-6246
Backup
Young Joon Hong, MD, PhD
hyj200@hanmail.net
82-2-220-5778
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 1500
Treatments
Active_comparator: Angiography-guided PCI
The PCI procedure in this group will be performed as standard procedure.
Experimental: Optical coherence tomography-guided PCI
Use of OCT will be allowed at any step of PCI (pre-PCI, during PCI and post-PCI), but OCT after stent implantation will be mandatory. In this group, the recommendations for selecting reference segment, selecting appropriate size of stent, and stent optimization are as follows. OPTIS imaging catheter (Abbott Vascular) will be used for the imaging arm according to MLD MAX algorithm.
Sponsors
Collaborators: Samsung Medical Center
Leads: Chonnam National University Hospital

This content was sourced from clinicaltrials.gov