RCVR (Residual CardioVascular Risk) Prospective Study

NCT06619353 | Active Not Recruiting

• 1 other identifier: CHAMC IRB 2024-01-054-004
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate whether residual cardiovascular risk assessed at 1 month after percutaneous coronary intervention (PCI) is associated with long-term clinical outcomes in adult patients with coronary artery disease who are free from major adverse clinical events at 1 month after PCI. The main questions it aims to answer are:

• Does residual cardiovascular risk at 1 month after PCI predict long-term net adverse clinical events?
• Which components of residual cardiovascular risk are associated with subsequent adverse clinical outcomes? Participants will:
• Undergo comprehensive laboratory testing at 1 month after PCI and annually thereafter.
• Undergo artificial intelligence-based quantitative coronary angiographic analysis using DICOM datasets after PCI.
• Be followed annually for up to 3 years after the 1-month assessment to evaluate clinical outcomes.

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Net adverse clinical event

  The composite of cardiovascular death, nonfatal spontaneous (nonprocedural) myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding.

  3 years after the 1-month assessment (baseline)

Secondary Outcomes (14)

• Cardiovascular death

  3 years after the 1-month assessment (baseline)

• Nonfatal spontaneous (nonprocedural) myocardial infarction

  3 years after the 1-month assessment (baseline)

• Nonfatal ischemic stroke

  3 years after the 1-month assessment (baseline)

• Unplanned hospitalization leading to urgent revascularization

  3 years after the 1-month assessment (baseline)

• Major bleeding

  3 years after the 1-month assessment (baseline)

Study Arms (1)

Residual CardioVascular Risk

Residual cardiovascular risk is assessed in patients undergoing PCI.

Diagnostic Test: Blood Sample; Other: DICOM Dataset

Interventions

Blood Sample DIAGNOSTIC_TEST

Patients' blood samples are tested at 1 month, and then annually for 3 years post-intervention to assess residual thrombotic, metabolic, and inflammatory risk.

Residual CardioVascular Risk

DICOM Dataset OTHER

Patients' DICOM dataset is evaluated using artificial intelligence-based quantitative coronary analysis to assess a procedural risk.

Residual CardioVascular Risk

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing PCI

You may qualify if:

• Patients who have undergone percutaneous coronary intervention.
• Patients who are free from death, myocardial infarction, stroke, unplanned revascularization, or major bleeding within 1 month after the index PCI.
• Patients who are able to undergo artificial intelligence-based quantitative coronary angiography using DICOM datasets.
• Patients who have provided written informed consent at the 1-month post-PCI visit.

You may not qualify if:

• 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.
• Occurrence of death, myocardial infarction, stroke, unplanned revascularization, or major bleeding within 1 month after the index PCI.
• Inability or unwillingness to comply with scheduled follow-up assessments.

Sponsors & Collaborators

• CHA University: lead

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Related Publications (3)

• 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.

  PMID: 32478100 BACKGROUND

• 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.

  PMID: 17470709 BACKGROUND

• 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.

  PMID: 21670242 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Seung-Yul Lee, MD

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

KR (1)