Invasive Versus Non-invasive Approach in Symptomatic Patients With Non-High Risk Coronary Artery Stenosis (SMART-STEP Trial)

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial. The study will compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive coronary artery disease (CAD) on coronary computed tomography-angiography (CCTA).

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

• Subject age ≥19 years old

• Patients with new or worsening chest pain syndrome, equivalent symptoms, or abnormal laboratory test findings (suspected ischemic changes in electrocardiography, regional wall motion abnormality in echocardiography, or coronary calcium score \> 100) suspected for clinically significant CAD who are evaluated by CCTA

• Any other clinical circumstance in which physician judged to proceed CCTA

• Obstructive CAD in CCTA (≥50% diameter stenosis)

• Subject who can verbally confirm understandings of risks, benefits, and treatment alternatives of receiving invasive approach 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
SoonChunHyang University Hospital Bucheon
RECRUITING
Bucheon-si
Kangwon National University Hospital
RECRUITING
Chuncheon
Chungbuk National University Hospital
RECRUITING
Chungju
Keimyung University Dongsan Medical Center
RECRUITING
Daegu
Kyungpook National University Hospital
RECRUITING
Daegu
Chungnam National University Hospital
RECRUITING
Daejeon
Chonnam National University
RECRUITING
Gwangju
Chung-Ang University Gwangmyeong Hospital
RECRUITING
Gwangmyeong
Inje university Ilsan Paik hospital
RECRUITING
Ilsan
Gachon University Gil Medical Center
RECRUITING
Incheon
Kwandong University Intl. ST. Mary's Hospital
RECRUITING
Incheon
Gyeongsang National University Hospital
RECRUITING
Jinju
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Chung-Ang University Hospital
RECRUITING
Seoul
Ewha Womans University Mokdong Hospital
RECRUITING
Seoul
Ewha Womans University Seoul Hospital
RECRUITING
Seoul
Hanyang University Seoul Hospital, College of Medicine, Hanyang University
RECRUITING
Seoul
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Boramae Medical Center
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Contact Information
Primary
Joo Myung Lee, MD, MPH, PhD
drone80@hanmail.net
82-2-3410-3391
Backup
David Hong, MD
hongdawi@naver.com
82-2-3410-3391
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 2000
Treatments
Experimental: Invasive approach group
Invasive coronary angiography will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA..
Active_comparator: Non-invasive approach group
Usual care of non-invasive ischemia testing (exercise electrocardiography \[ECG\], stress echocardiography by exercise or pharmacologic agent, nuclear test including SPECT or PET, stress cardiac magnetic resonance \[MR\]) will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA.
Related Therapeutic Areas
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov