Disease Characteristics of IR-CAD: a Case-control Study

NCT06007248 | Recruiting

• 1 other identifier: K3819
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD.

Conditions

Coronary Artery Disease; Coronary Artery Stenosis; Coronary Artery Restenosis; Coronary Artery Disease Progression; Inflammation; Inflammatory Disease; Inflammation Vascular

Keywords

Coronary Artery Disease; Coronary Revascularization; Progression, Disease; Inflammation; Characteristics Disease

Outcome Measures

Primary Outcomes (1)

• Elevated erythrocyte sedimentation rate (ESR)

  Percentage of patients with elevated ESR (\> 15 mm for male or \> 20 mm for female). In case of normal ESR, prior use of immunosuppressive therapy or prior diagnosis of autoimmune diseases before enrollment is regarded as the equivalent to elevated ESR.

  From the last coronary revascularization up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.

Secondary Outcomes (106)

• Age

  On the day of enrollment.

• Female sex

  On the day of enrollment.

• Yellow race

  On the day of enrollment.

• Acute coronary syndrome (ACS)

  On the day of enrollment.

• Chronic coronary syndrome (CCS).

  On the day of enrollment.

Other Outcomes (4)

• Maximum standardized uptake value (SUVmax)

  From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.

• RNA sequencing

  From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.

• Proteomics

  From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.

Study Arms (2)

Case Group

IR-CAD patients (from the IR-CAD cohort study)

Diagnostic Test: Protocol-defined Examinations

Control Group

AS-CAD patients

Diagnostic Test: Protocol-defined Examinations

Interventions

Protocol-defined Examinations 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, Birmingham Vasculitis Activity Score (BVAS-3), 6-minute walk test, 1-minute squat test, vascular ultrasound, fibroblast activation protein inhibitor (FAPI) positron emission tomography/computed tomography (PET/CT), coronary angiography, optical coherence tomography (OCT), tests for exploratory biomarkers.

Case Group; Control Group

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The first 20 patients who were enrolled in the IR-CAD cohort study, which included patients who met the inclusion/exclusion criteria for IR-CAD and received comprehensive treatment, will be enrolled in the case group of the present IR-CAD case-control study. Patients who fulfill the inclusion/exclusion criteria for AS-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 (IR-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 coronary artery bypass graft \[CABG\]).
• Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization.
• Hospitalization due to rapidly-progressive myocardial ischemia:
• Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV) and non-invasive evidence of myocardial ischemia; and
• Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization.
• Angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
• Evidence of inflammation:
• At least one of the indexes indicating active inflammation has ever been elevated (ESR, high-sensitivity C-reactive protein \[hs-CRP\], interleukin \[IL\]-6, tumor necrosis factor \[TNF\]-α, ferritin, et al); or
• Established diagnosis of systemic autoimmune disease or systemic vasculitis; or
• Receiving immunosuppressive therapy.
• Control group (AS-CAD patients):
• ≥ 45 and \< 65 years of age (based on the age distribution of the patients currently enrolled in the IR-CAD cohort study), male or female.

You may not qualify if:

• Case group (IR-CAD patients):
• 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 acute or chronic infection (human immunodeficiency virus \[HIV\], tuberculosis, et al).
• Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
• Vital organ failure.
• Life expectancy \< 1 year.
• Contraindications for or intolerance to treatment for secondary prevention of AS-CAD, contrast agents, glucocorticoids, immunosuppressive agents.
• 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.
• Control group (AS-CAD patients):

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

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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; Inflammation; Disease Progression

Condition Hierarchy (Ancestors)

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

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

Study Design

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

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 23, 2023
• Study Start: November 2, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)