2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes.
Juhani Knuuti, William Wijns, Antti Saraste...
https://pubmed.ncbi.nlm.nih.gov/31504439Actively Recruiting
Age: 45Years - 64Years
All Genders
ID06007248
Disease Characteristics of Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Case-control Study
Led by Peking Union Medical College Hospital · Updated on 2025-11-19
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a special form of coronary artery disease called inflammation-associated rapidly-progressive coronary artery disease (IR-CAD), which shows very different features from typical atherosclerotic coronary artery disease (AS-CAD). This study compares 20 patients with IR-CAD to 10 patients with AS-CAD to better understand the differences in demographics, clinical signs, lab results, imaging findings, and previous treatments. The goal is to clarify the disease characteristics of IR-CAD, which progresses quickly, recurs often, and does not respond well to usual treatments after coronary interventions. The study groups include IR-CAD patients receiving comprehensive treatment involving intensified secondary prevention, immunosuppressive therapy, coronary revascularization, and supportive care. The control group consists of AS-CAD patients aged 45 to under 65 years who are on standard secondary prevention after coronary intervention without rapidly progressive ischemia or new coronary lesions. Both groups undergo detailed examinations including blood and urine tests, heart imaging, vascular ultrasound, PET/CT scans, coronary angiography, and other biomarker assessments as defined by the study protocol. Participants provide information on various health measures such as inflammation markers, cardiac biomarkers, imaging results, and physical function tests like the 6-minute walk and 1-minute squat tests. The main measure is the rate of elevated erythrocyte sedimentation rate (ESR), a marker of inflammation. Researchers will compare this and other health data between groups. The study involves careful collection and analysis of clinical, lab, and imaging data up to the point of enrollment before new treatments begin. The total study duration extends to September 2026.
CONDITIONS
Brief Title
Disease Characteristics of IR-CAD: a Case-control Study
Who Can Participate
Age: 45Years - 64Years
All Genders
Eligibility Criteria
You may qualify if you...
- Case group: 18 years or older, male or female
- Negative pregnancy test for females with childbearing potential
- Prior coronary revascularization (PCI or CABG)
- Receiving standard treatment for secondary prevention after last coronary revascularization
- Hospitalized due to rapidly-progressive myocardial ischemia with typical angina symptoms
- Angiographic evidence of new coronary lesions relevant to ischemia
- Evidence of inflammation by markers, autoimmune disease diagnosis, or immunosuppressive therapy
- Control group: aged 45 to under 65 years, male or female
- Negative pregnancy test for females with childbearing potential
- 12±6 months after last PCI
- Receiving standard treatment for secondary prevention after last PCI
- Coronary angiography or OCT performed during hospitalization
- No evidence of rapidly-progressive myocardial ischemia
- No angiographic evidence of new coronary lesions relevant to ischemia
You will not qualify if you...
- Coronary restenosis due to mechanical factors
- Moderate to severe other heart diseases (e.g., congenital, valvular, myocarditis, cardiomyopathy, pulmonary hypertension, heart failure, arrhythmia)
- Active acute or chronic infection (e.g., HIV, tuberculosis)
- Active malignancy within 12 months or requiring treatment
- Vital organ failure
- Life expectancy less than 1 year
- Contraindications or intolerance to treatments for secondary prevention, contrast agents, glucocorticoids, or immunosuppressants
- Pregnancy, breastfeeding, or intention to become pregnant during the study
- Risk of non-compliance such as drug addiction or alcohol abuse
- Previous enrollment in this study
- Participation in another study within 30 days
- Involvement in planning or conduct of this study
- Any condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 2 weeks before enrollment
Participants undergo protocol-defined examinations including lab tests, electrocardiography, echocardiography, vascular ultrasound, PET/CT scans, coronary angiography, and other specialized assessments to characterize disease features.
1 to 2 visits depending on group assignment
Long-term Monitoring
Duration - Up to the day of enrollment
Participants are observed to collect information on clinical features, lab results, imaging findings, and prior treatments for comparison between groups.
No specific visits; observation and data collection occur as part of routine care
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
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Research Team
Z
Zhenyu Liu, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/288866212020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation.
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Dawn M Fernandez, Chiara Giannarelli
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https://pubmed.ncbi.nlm.nih.gov/34251531Therapeutic strategies targeting inflammation and immunity in atherosclerosis: how to proceed?
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Bradley Tucker, Kaivan Vaidya, Blake J Cochran...
https://pubmed.ncbi.nlm.nih.gov/34199975Residual inflammatory risk and the impact on clinical outcomes in patients after percutaneous coronary interventions.
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https://pubmed.ncbi.nlm.nih.gov/30358832Residual Inflammatory Risk in Patients With Low LDL Cholesterol Levels Undergoing Percutaneous Coronary Intervention.
Paul Guedeney, Bimmer E Claessen, Deborah N Kalkman...
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