Clinical Features, Current Treatment and Clinical Outcomes in Patients With Inflammation-associated Non-rapidly-progressive Coronary Artery Disease (INR-CAD): a Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Major adverse cardiovascular events (MACE)
Study Overview
Brief Summary
This is a cohort study to investigate the clinical features, current treatment and clinical outcomes in patients with inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD).
Detailed Description
A special type of coronary artery disease (CAD) has been identified in our clinical practice. The patients have significantly different clinical features from those of typical atherosclerotic coronary artery disease (AS-CAD), including: 1) predominantly female; 2) early onset CAD; 3) lack of traditional atherosclerotic risk factors; 4) often with evidence of chronic inflammation; 5) responding poorly to intensified secondary prevention and optimized coronary revascularization (percutaneous coronary intervention [PCI] or coronary bypass graft [CABG]); 6) delayed disease progression on immunosuppressive therapy. This special type of CAD is named with inflammation-associated coronary artery disease (I-CAD). Currently, the pathogenesis as well as the optimal approach regarding the diagnosis and treatment of I-CAD remain unknown.
Based on the rate of disease progression and the urgency for clinical management, I-CAD is classified into two categories: 1) inflammation-associated rapidly-progressive coronary artery disease (IR-CAD), which is defined as I-CAD with progression of coronary de novo and/or restenotic lesions within 6 months or within 12 months (only for patients receiving immunosuppressive therapy within 24 months); 2) inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD), which is defined as I-CAD not fulfilling the criteria for IR-CAD.
It has been recognized in our clinical practice that INR-CAD is a highly heterogeneous group of diseases. Therefore, the present observational cohort study was designed to investigate the clinical features, current treatment and clinical outcomes in patients with INR-CAD.
All patients who have been admitted to the Department of Cardiology, Peking Union Medical College Hospital (PUMCH) since January 1, 2022 will be screened for study participation. Clinical diagnostic criteria and a clinical follow-up protocol have been specifically designed for INR-CAD in our center. Patients are clinically diagnosed as INR-CAD if they 1) have angiographic evidence of coronary lesions (de novo or restenotic); 2) have evidence of chronic inflammation (positive inflammatory markers or positive autoantibodies or established diagnosis of chronic inflammatory diseases or use of immunosuppressive therapy) within 24 months; 3) not meet the clinical diagnostic criteria for IR-CAD. Once the clinical diagnosis is established, INR-CAD patients will receive a 24-month clinical follow-up according to the clinical follow-up protocol for INR-CAD in PUMCH. Patients who have been clinically diagnosed as INR-CAD and received, or are receiving, or will receive the 24-month clinical follow-up will be enrolled in the present cohort study.
The primary efficacy endpoint is major adverse cardiovascular events (MACE). The secondary efficacy endpoints include the individual components of MACE, exercise capacity, angiographic metrics of coronary lesions, and inflammatory markers. The safety endpoints are major bleeding events and severe infection events.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
- •Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
- •Vital organ failure.
- •Life expectancy < 1 year.
- •In pregnancy or breast-feeding, or with intention to be pregnant during the study period.
- •Risk of non-compliance (history of drug addiction or alcohol abuse, et al).
- •Previous enrollment in this study.
- •Participation in another study within 30 days.
- •Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al).
- •Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study.
Arms & Interventions
INR-CAD Group
Patients who have been clinically diagnosed as INR-CAD and received, or are receiving, or will receive the 24-month clinical follow-up according to the clinical diagnostic criteria and follow-up protocol for INR-CAD.
Intervention: Healthy life style (Behavioral)
INR-CAD Group
Patients who have been clinically diagnosed as INR-CAD and received, or are receiving, or will receive the 24-month clinical follow-up according to the clinical diagnostic criteria and follow-up protocol for INR-CAD.
Intervention: Secondary prevention for atherosclerotic coronary artery disease (Drug)
INR-CAD Group
Patients who have been clinically diagnosed as INR-CAD and received, or are receiving, or will receive the 24-month clinical follow-up according to the clinical diagnostic criteria and follow-up protocol for INR-CAD.
Intervention: Immunosuppressive Therapy (Drug)
INR-CAD Group
Patients who have been clinically diagnosed as INR-CAD and received, or are receiving, or will receive the 24-month clinical follow-up according to the clinical diagnostic criteria and follow-up protocol for INR-CAD.
Intervention: Coronary revascularization (Procedure)
INR-CAD Group
Patients who have been clinically diagnosed as INR-CAD and received, or are receiving, or will receive the 24-month clinical follow-up according to the clinical diagnostic criteria and follow-up protocol for INR-CAD.
Intervention: Supportive therapies (Drug)
Outcomes
Primary Outcomes
Major adverse cardiovascular events (MACE)
Time Frame: From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
The composite endpoint including death, or Q-wave myocardial infarction, or unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or unplanned myocardial ischemia-driven hospitalization.
Secondary Outcomes
- Death(From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.)
- Q-wave myocardial infarction(From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.)
- Unplanned myocardial ischemia-driven coronary revascularization(From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.)
- Unplanned myocardial ischemia-driven hospitalization(From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.)
- Walking distance in 6 minutes(At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.)
- Target lesion minimal lumen area (TL-MLA)(At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.)
- Target lesion percent area stenosis (TL-%AS)(At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.)
- SYNTAX score(At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.)
- Number of vessel segments with coronary lesions(At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.)
- Erythrocyte sedimentation rate (ESR)(At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.)
- High-sensitivity C-reactive protein (hs-CRP)(At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.)
- Interleukin-6 (IL-6)(At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.)
- Tumor necrosis factor-alpha (TNF-α)(At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.)
Investigators
LiuZhenyu
Professor
Peking Union Medical College Hospital