Investigating characteristics of a special type of coronary artery disease

Disease Characteristics of Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Case-control Study

This study is trying to understand the unique features of a fast-progressing type of coronary artery disease by comparing patients with this condition to those with a more common form of the disease.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 45 Years to 64 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06007248 on ClinicalTrials.gov

What this trial studies

This observational case-control study aims to explore the unique disease characteristics of inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing 20 patients diagnosed with IR-CAD to 10 patients with typical atherosclerotic coronary artery disease (AS-CAD). The study will assess various factors including demographics, clinical features, lab results, imaging findings, and prior treatments. Patients with IR-CAD exhibit rapid disease progression and poor response to standard treatments, making this investigation crucial for understanding their specific needs and treatment responses.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a history of coronary revascularization and evidence of rapidly progressive myocardial ischemia.

Not a fit: Patients without a history of coronary revascularization or those with stable coronary artery disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management strategies for patients with IR-CAD.

How similar studies have performed: While the specific characteristics of IR-CAD are novel, similar studies on coronary artery disease have shown varying degrees of success in understanding disease progression and treatment responses.

Eligibility criteria

Inclusion Criteria:

Case group (IR-CAD patients):

1. 18 years of age or older, male or female.
2. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
3. Prior history of coronary revascularization (PCI or coronary artery bypass graft \[CABG\]).
4. Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization.
5. 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.
6. Angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
7. 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):

1. ≥ 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.
2. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
3. Currently, 12±6 months after the last PCI.
4. Receiving standard treatment for secondary prevention of AS-CAD after the last PCI.
5. Coronary angiography and/or optical coherence tomography (OCT) performed during the present hospitalization.
6. No evidence of rapidly-progressive myocardial ischemia, which is defined as follows:

   * 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 PCI.
7. No angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.

Exclusion Criteria:

Case group (IR-CAD patients):

1. Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).
2. Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
3. Active acute or chronic infection (human immunodeficiency virus \[HIV\], tuberculosis, et al).
4. Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
5. Vital organ failure.
6. Life expectancy \< 1 year.
7. Contraindications for or intolerance to treatment for secondary prevention of AS-CAD, contrast agents, glucocorticoids, immunosuppressive agents.
8. In pregnancy or breast-feeding, or with intention to be pregnant during the study period.
9. Risk of non-compliance (history of drug addiction or alcohol abuse, et al).
10. Previous enrollment in this study.
11. Participation in another study within 30 days.
12. Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al).
13. 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):

The same as those for the case group (IR-CAD patients).

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhenyu Liu, M.D. — Peking Union Medical College Hospital
• Study coordinator: Zhenyu Liu, M.D.

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