Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05860400
Status:
RECRUITING
Last Update Posted:
2023-07-11
First Post:
2023-05-08
Brief Title:
Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD a Self-controlled Cohort Study
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Efficacy and Safety of Comprehensive Treatment in Patients With Inflammation-associated Rapidly-progressive Coronary Artery Disease IR-CAD a Self-controlled Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 andor 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 andor 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 eg 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 eg 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
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 andor 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 eg 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None