Evaluating comprehensive treatment for rapidly-progressive coronary artery disease

Efficacy and Safety of Comprehensive Treatment in Patients With Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Self-controlled Cohort Study

This study is testing a new treatment plan for people with rapidly-progressive coronary artery disease that includes medication and procedures to see if it helps them feel better and manage their condition.

Quick facts

• Study type: Observational
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05860400 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the efficacy and safety of a comprehensive treatment approach for patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD). It involves a self-controlled cohort design, where patients will be evaluated before and after receiving a combination of intensified secondary prevention, immunosuppressive therapy, coronary revascularization, and supportive therapies. The study focuses on patients who have experienced rapid disease progression and have evidence of inflammation. By comparing outcomes within the same group, the study seeks to identify effective management strategies for this unique patient population.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 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 provide a new comprehensive treatment strategy that improves outcomes for patients with rapidly-progressive coronary artery disease.

How similar studies have performed: While the approach is novel for IR-CAD, similar studies in other forms of coronary artery disease have shown promising results with comprehensive treatment strategies.

Eligibility criteria

Inclusion Criteria:

1. Fulfilling all the following criteria before initiation of comprehensive treatment:

   1.1 18 years of age or older, male or female.

   1.2 Negative result of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).

   1.3 Prior history of coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]).

   1.4 Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease (AS-CAD) after the last coronary revascularization.

   1.5 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.

   1.6 Angiographic evidence of new coronary lesions (de novo stenoses or restenoses):
   * Occurred after the last coronary revascularization; and
   * Related to myocardial ischemia (location, extent, severity, et al).

   1.7 Evidence of inflammation:
   * At least one of the markers indicating active inflammation has ever been elevated (erythrocyte sedimentation rate \[ESR\], 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.
2. Receiving comprehensive treatment, including ischemia-driven PCI which was performed no earlier than 40 days of the initiation of immunosuppressive therapy.

Exclusion Criteria:

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.

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