Evaluating comprehensive treatment for rapidly-progressive coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: Pumch_lzy@163.com
• Phone: +861069155068

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Clinical features, treatments, and outcomes in inflammation-associated non-rapidly-progressive coronary artery disease

  This study will see how current treatments, inflammation markers, and patient characteristics relate to outcomes in people with inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD).

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06845410

• Investigating characteristics of a special type of coronary artery disease

  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.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06007248

• Evaluating vessel imaging for coronary artery disease

  This study is testing if a special imaging technique can help doctors better understand plaque in the arteries of people with heart issues and see how it relates to blood flow.

  Recruiting Medical University of Warsaw · Warsaw, Mazowieckie Voivodenship · NCT06844942

• IRIS Coroflex NEO stent registry

  This project tests whether Coroflex ISAR NEO drug-eluting stents are safe and work well for adults having percutaneous coronary intervention for coronary artery disease.

  Recruiting at 7 sites Asan Medical Center · Seoul, Songpa-gu and 10 other locations · NCT06177743

• μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease

  This trial tests whether using computational μFR guidance during drug-coated balloon angioplasty is better than standard angiography guidance for people with de novo coronary artery lesions.

  Recruiting Centro Cardiologico Monzino · Cosenza, CS and 3 other locations · NCT07917234

• Gastric Ultrasound Before CABG to See if Heart Function Changes Stomach Contents

  This study checks whether people with weaker heart function before elective CABG have different stomach contents seen on ultrasound.

  Recruiting Adiyaman University · Adıyaman · NCT07898215

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.