Evaluating the impact of coronary CT angiography and treatment on heart health outcomes
Impact of Stenosis and Plaque Features in Coronary CT Angiography, Physiologic Assessment and Pharmacotherapy on the Clinical Outcomes After Invasive Coronary Angiography
This study is trying to see how using coronary CT scans to check heart artery blockages and plaque can help doctors decide the best treatment for people with coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 992 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Select) |
| Trial ID | NCT04547231 on ClinicalTrials.gov |
What this trial studies
This study investigates how the severity of stenosis and plaque characteristics observed through coronary CT angiography (CCTA) influence clinical outcomes in patients with coronary artery disease. It aims to assess the prognostic value of these features alongside physiological assessments like fractional flow reserve (FFR) and the effects of pharmacotherapy. By comparing outcomes in patients who undergo invasive procedures versus those who receive optimal medical therapy, the study seeks to enhance risk stratification and treatment strategies for coronary artery disease. The research will involve both observational data collection and analysis of patient outcomes post-treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and older who have undergone coronary CT angiography and require further assessment of their coronary artery disease management.
Not a fit: Patients with severe left ventricular dysfunction, recent acute myocardial infarction, or those who have undergone previous coronary artery bypass graft surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and treatment strategies for patients with coronary artery disease.
How similar studies have performed: Previous studies have shown that incorporating advanced imaging and physiological assessments can improve patient outcomes, suggesting a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
1) Deferral of PCI group Inclusion Criteria: 1. Age ≥ 20 years 2. Patients who undergo CCTA within 90 days before FFR measurement by clinical needs 3. Patients with a vessel determined to defer revascularization after FFR measurement. Exclusion Criteria: 1. Left ventricular ejection fraction \< 35% 2. Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery 3. Abnormal epicardial coronary flow (TIMI flow \< 3) 4. Failed FFR measurement 5. Planned coronary artery bypass graft surgery after diagnostic angiography 6. Poor quality of CCTA which is unsuitable for plaque analysis 7. Patients with a stent in the target vessel 2) PCI group Inclusion Criteria: 1. Age ≥ 20 years 2. Patients who undergo CCTA within 90 days before FFR measurement by clinical needs 3. Patients with a vessel that undergo stent implantation and FFR measurement both before and after revascularization (pre-PCI FFR and post-PCI FFR). * Patients with multiple vessels that meet inclusion criteria of the deferral of PCI group and PCI group will be assigned to the PCI group. Exclusion Criteria: 1. Left ventricular ejection fraction \< 35% 2. Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery 3. Abnormal epicardial coronary flow (TIMI flow \< 3) 4. Failed FFR measurement 5. Planned coronary artery bypass graft surgery after diagnostic angiography 6. Poor quality of CCTA which is unsuitable for plaque analysis 7. Patients with a stent in the target vessel
Where this trial is running
Seoul, Select
- Seoul National University Hospital — Seoul, Select, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Bon-Kwon Koo, MD, PhD
- Email: bkkoo@snu.ac.kr
- Phone: +82-1033561869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.