Disease Characteristics of R-CAD

NCT07239921 | Not Yet Recruiting

• 1 other identifier: K9096
• Study Type: observational
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present case-control study is designed to investigate the disease characteristics of rapidly progressive coronary artery disease (R-CAD) by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between patients in the case group (approximately 34 patients with R-CAD) and those in the control group (approximately 18 patients with non-rapidly progressive coronary artery disease \[NR-CAD\]).

Conditions

Coronary Artery Disease; Coronary Artery Disease Progression; Coronary Stenosis; Coronary Restenosis; Coronary Stent Occlusion; Myocardial Revascularization; Percutaneous Coronary Intervention

Keywords

Coronary Artery Disease; Coronary Stenosis; Coronary Restenosis; Myocardial Revascularization; Percutaneous Coronary Intervention; Disease Progression; Disease Attributes

Outcome Measures

Primary Outcomes (1)

• Elevated ESR or hs-CRP

  Percentage of patients with elevated ESR (\> 15 mm/h for male or \> 20 mm/h for female) or hs-CRP (≥ 2 mg/L).

  From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.

Secondary Outcomes (4)

• Positive autoantibodies

  From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.

• Established diagnosis of chronic inflammatory diseases

  Up to 14 days after enrollment

• Elevated ESR or hs-CRP, or positive autoantibodies

  From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.

• Elevated ESR or hs-CRP, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases

  For elevated ESR or hs-CRP and positive autoantibodies: from 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy; for established diagnosis of chronic inflammatory diseases: up to 14 days after

Other Outcomes (3)

• Maximum standardized uptake value (SUVmax)

  From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.

• Maximum target background ratio (TBRmax)

  From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.

• Fat attenuation index (FAI)

  From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.

Study Arms (2)

Case Group

R-CAD patients

Diagnostic Test: Protocol-defined Examinations and Evaluations

Control Group

NR-CAD patients

Diagnostic Test: Protocol-defined Examinations and Evaluations

Interventions

Protocol-defined Examinations and Evaluations DIAGNOSTIC_TEST

Lab tests (blood and urine and stool routine tests, hepatic and renal and thyroid function tests, tests for metabolic markers, tests for cardiac biomarkers, thrombosis-related tests, rheumatology tests, tests for inflammation markers), electrocardiography, echocardiography, 6-minute walk test, vascular ultrasound, coronary angiography, optical coherence tomography (OCT), fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT), photon-counting detector coronary computed tomography angiography (PCD-CCTA), tests for exploratory biomarkers.

Case Group; Control Group

Eligibility Criteria

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

Study Population

Patients who fulfill the inclusion/exclusion criteria for R-CAD defined by the protocol of the present case-control study will be enrolled in the case group of the present case-control study. Patients who fulfill the inclusion/exclusion criteria for NR-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study.

You may qualify if:

• Case Group (R-CAD patients):
• years of age or older, male or female.
• Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
• Prior history of coronary revascularization (PCI or CABG).
• Receiving standard treatment for secondary prevention of AS-CAD after the latest coronary revascularization.
• Rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization:
• Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] classification III-IV) and non-invasive evidence of myocardial ischemia; and
• Occurred within 6 months of the latest ischemia-driven hospitalization and/or coronary revascularization.
• Rapidly progressive coronary lesions leading to myocardial ischemia:
• Angiographic evidence of new-onset or worsened coronary de novo or restenotic lesions relevant to myocardial ischemia, and
• Occurred within 6 months of the latest ischemia-driven coronary angiography and/or revascularization.
• Control Group (NR-CAD patients):
• to 75 years old\*, male or female. (\* Based on the age distribution characteristics of patients who have been diagnosed as R-CAD.)
• Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
• Currently, at 12±6 months after the latest PCI.

You may not qualify if:

• Receiving immunosuppressive therapy within 6 months.
• Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).
• Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
• Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
• Vital organ failure.
• Life expectancy \< 1 year.
• In pregnancy or breast-feeding, or with intention to be pregnant during the study period.
• Risk of non-compliance (history of drug addiction or alcohol abuse, et al).
• Previous enrollment in this study.
• Participation in another study within 30 days.
• Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al).
• Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be retained for exploratory tests, including RNA sequencing, proteomics, and metabolomics, et al.

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Coronary Restenosis; Disease Progression; Disease Attributes

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Zhenyu Liu, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenyu Liu, M.D.

CONTACT

+861069155068; Pumch_lzy@163.com

Lihong Xu, B.N.

CONTACT

+861069155068; xulihong1990@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share