Disease Characteristics of R-CAD

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

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 \[NR-CAD\]).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Case Group1 intervention
Group B: Control Group1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

Positive autoantibodies

Percentage of patients with positive autoantibodies (anti-nuclear antibody \[ANA\], anti-neutrophil cytoplasmic antibody \[ANCA\], anti-endothelial cell antibody \[AECA\], lupus anticoagulant \[LA\], antiphospholipid antibody (APL) (anti-cardiolipin antibody \[ACL\], anti-beta2-glycoprotein 1 antibody \[abeta2GP1\]), anti-phosphatidylserine antibody \[APSA\], rheumatoid factor \[RF\], anti-cyclic citrullinated peptide antibody \[anti-CCP\], et al.).

Time frame
From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
2

Established diagnosis of chronic inflammatory diseases

Percentage of patients with established diagnosis of chronic inflammatory diseases (chronic infectious disease, autoimmune disease, other chronic inflammatory diseases, et al.).

Time frame
Up to 14 days after enrollment
3

Elevated ESR or hs-CRP, or positive autoantibodies

Percentage of patients with elevated ESR or hs-CRP, or positive autoantibodies.

Time frame
From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
4

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

Percentage of patients with elevated ESR or hs-CRP, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases.

Time frame
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

1

Maximum standardized uptake value (SUVmax)

SUVmax based on fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT).

Time frame
From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
2

Maximum target background ratio (TBRmax)

TBRmax based on fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT).

Time frame
From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
3

Fat attenuation index (FAI)

FAI based on photon-counting detector coronary computed tomography angiography (PCD-CCTA).

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

Locations

This trial has no locations.

Sponsors and contacts

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