Clinical trial NCT06619353: RCVR (Residual CardioVascular Risk) Prospective Multicenter Study
Official title: Residual CardioVascular Risk (RCVR) After Percutaneous Coronary Intervention: a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing PCI

Brief summary: The observational study aims to evaluate the long-term effects of residual cardiovascular risk on clinical outcomes following percutaneous coronary intervention (PCI). This risk includes thrombotic, metabolic, inflammatory, and procedural factors, which are assessed 1 month after the intervention. The primary question the study seeks to answer is:

What residual cardiovascular risk affects long-term clinical outcomes in patients undergoing PCI?

Participants will undergo artificial intelligence-based quantitative coronary analysis after PCI and will have comprehensive laboratory tests conducted at 1 month to evaluate residual cardiovascular risk, and then annually for 3 years post-intervention to assess changes in this risk.


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone percutaneous coronary intervention.
* Patients who have provided written informed consent.

Exclusion Criteria:

* Under 19 years of age.
* Pregnant, breastfeeding, or women of childbearing age.
* Currently has a malignancy or has a history of malignancy within the past 5 years.
* Life expectancy of less than 5 years.

Primary outcomes:
measure: Net adverse clinical event
timeFrame: 3 years post-intervention
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 3 years post-intervention
measure: Nonfatal spontaneous (nonprocedural) myocardial infarction
timeFrame: 3 years post-intervention
measure: Nonfatal ischemic stroke
timeFrame: 3 years post-intervention
measure: Unplanned hospitalization leading to urgent revascularization
timeFrame: 3 years post-intervention
measure: Major bleeding
timeFrame: 3 years post-intervention
measure: V-Angiographic success
timeFrame: Within 1 hour post-intervention
measure: V-Complete revascularization
timeFrame: Within 1 hour post-intervention
measure: AI-Angiographic success
timeFrame: Within 1 hour post-intervention
measure: AI-Complete revascularization
timeFrame: Within 1 hour post-intervention
measure: Platelet reactivity
timeFrame: 1 month, 1 year, 2 years, and 3 years post-intervention
measure: Thrombogenicity profiles
timeFrame: 1 month, 1 year, 2 years, and 3 years post-intervention
measure: Lipid profiles
timeFrame: 1 month, 1 year, 2 years, and 3 years post-intervention
measure: Hemoglobin A1C
timeFrame: 1 month, 1 year, 2 years, and 3 years post-intervention
measure: High-sensitivity C-reactive protein
timeFrame: 1 month, 1 year, 2 years, and 3 years post-intervention
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
affiliation: CHA Bundang Medical Center
name: Seung-Yul Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhindsa DS, Sandesara PB, Shapiro MD, Wong ND. The Evolving Understanding and Approach to Residual Cardiovascular Risk Management. Front Cardiovasc Med. 2020 May 13;7:88. doi: 10.3389/fcvm.2020.00088. eCollection 2020.
citation: Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.
citation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.