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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-64
SponsorPeking Union Medical College Hospital

About this trial

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.

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 coronary artery bypass graft [CABG]).

Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

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

Trial outcomes

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.

Time frame
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

1

Age

Age in years.

Time frame
On the day of enrollment.
2

Female sex

Percentage of patients with female sex.

Time frame
On the day of enrollment.
3

Yellow race

Percentage of patients with yellow race.

Time frame
On the day of enrollment.
4

Acute coronary syndrome (ACS)

Percentage of patients admitted due to ACS for the index hospitalization.

Time frame
On the day of enrollment.

Other outcomes

1

Maximum standardized uptake value (SUVmax)

The mean of SUVmax of each major coronary artery on fibroblast activation protein inhibitor (FAPI) positron emission tomography/computed tomography (PET/CT).

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

RNA sequencing

Test result of RNA sequencing.

Time frame
From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
3

Proteomics

Test result of proteomics.

Time frame
From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
4

Metabolomics

Test result of metabolomics.

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

Sponsors and contacts

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