Clinical Trials Logo

Clinical Trial Summary

This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.


Clinical Trial Description

A special type of coronary artery disease (CAD) has been identified in our clinical practice, which has completely different clinical features from those of typical atherosclerotic coronary artery disease (AS-CAD). The patients often have sterile inflammatory diseases and/or clinical evidence of inflammation, whose CAD progresses rapidly, recurs frequently, and responds poorly to intensified secondary prevention of AS-CAD, especially after percutaneous coronary intervention (PCI). We name this special type of CAD inflammation-associated rapidly-progressive coronary artery disease (IR-CAD). The optimal treatment for IR-CAD remains unknown. We hypothesize that the rapid progression of IR-CAD might be associated with inflammation considering that: 1) inflammation is associated with poor prognosis in CAD patients after PCI; 2) IR-CAD patients often have sterile inflammatory diseases and/or clinical evidence of inflammation; 3) the disease progression of IR-CAD can be controlled to some extent with corticosteroids and immunosuppressive agents. Therefore, we incorporate immunosuppressive therapy into the overall management strategy of IR-CAD patients in clinical practice, developing comprehensive treatment, including: 1) intensified secondary prevention of AS-CAD; 2) immunosuppressive therapy; 3) coronary revascularization; 4) supportive therapies. The present self-controlled cohort study is designed to evaluate the efficacy and safety of comprehensive treatment in about 39 IR-CAD patients by comparing the outcomes before with those after the initiation of comprehensive treatment in the same group of patients. All patients who were admitted to the Department of Cardiology, Peking Union Medical College Hospital on and after January 1, 2022 will be screened for study participation. Patients were diagnosed as IR-CAD if they presented with 1) rapidly progressive myocardial ischemia (typical symptoms and non-invasive evidence) despite standard treatment for secondary prevention of AS-CAD after the last coronary revascularization; 2) angiographic evidence of new coronary lesions (de novo stenosis or restenosis) related to myocardial ischemia; 3) evidence of inflammation (positive inflammation markers or established diagnoses of inflammatory diseases or use of immunosuppressive therapy). IR-CAD patients who have received comprehensive treatment will be enrolled in the present cohort study. The eligible patients will be followed for 24 months since the initiation of comprehensive treatment. The primary efficacy endpoint is major adverse cardiovascular events (MACE). The key secondary efficacy endpoint is target vessel related major adverse cardiovascular events (TV-MACE). Other secondary efficacy endpoints include individual components of MACE and TV-MACE, exercise capacity, angiographic metrics of coronary lesions, and inflammation markers. The safety endpoints are major bleeding events and severe infection events. For endpoints which are categorical variables, e.g., MACE, survival analysis will be used to compare the survival curves before treatment (from the last coronary revascularization before the initiation of comprehensive treatment to the first occurrence of MACE) with those after treatment (from the initiation of comprehensive treatment to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first). Event-free survival rates and relative risk will be calculated. For endpoints which are continuous variables, e.g., inflammation markers, paired t-test or paired rank sum test will be used to compare the endpoint levels before treatment (before the initiation of comprehensive treatment or at baseline) with those after treatment (the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, after the initiation of comprehensive treatment). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05860400
Study type Observational [Patient Registry]
Source Peking Union Medical College Hospital
Contact Zhenyu Liu, M.D.
Phone +861069155068
Email Pumch_lzy@163.com
Status Recruiting
Phase
Start date May 17, 2023
Completion date September 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A