Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007248
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-07-07
Brief Title:
Disease Characteristics of IR-CAD a Case-control Study
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Disease Characteristics of Inflammation-associated Rapidly-progressive Coronary Artery Disease IR-CAD a Case-control Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
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:
The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics clinical features lab results imaging findings and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD
Detailed Description:
A special type of coronary artery disease CAD has been identified in the investigators 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 The investigators name this special type of CAD with inflammation-associated rapidly-progressive coronary artery disease IR-CAD Currently the overall disease characteristics of IR-CAD remain unknown
The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics clinical features lab results imaging findings and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD
The first 20 patients who were enrolled in the IR-CAD cohort study which included patients who met the inclusionexclusion criteria for IR-CAD and received comprehensive treatment will be enrolled in the case group of the present IR-CAD case-control study Patients were diagnosed as IR-CAD if they have 1 evidence of rapidly progressive occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization myocardial ischemia typical symptoms and non-invasive evidence despite standard treatment for secondary prevention of AS-CAD 2 angiographic evidence of new coronary lesions de novo stenosis or restenosis considered to be relevant to myocardial ischemia 3 evidence of inflammation positive inflammation markers or established diagnosis of inflammatory diseases or use of immunosuppressive therapy The comprehensive treatment for IR-CAD included 1 intensified secondary prevention of AS-CAD 2 immunosuppressive therapy 3 coronary revascularization 4 supportive therapies
Patients who fulfill the inclusionexclusion criteria for AS-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study Patients will be diagnoses as AS-CAD if they 1 are 45 but 65 years of age 2 are receiving standard treatment for secondary prevention of AS-CAD after the last PCI which was performed 126 months ago 3 do not have evidence of rapidly progressive occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI myocardial ischemia typical symptoms and non-invasive evidence 4 do not have angiographic evidence of new coronary lesions de novo stenosis or restenosis considered to be relevant to myocardial ischemia
Patients in the IR-CAD cohort study underwent examinations after they met the inclusionexclusion criteria for IR-CAD based on a protocol specifically designed for the clinical management of IR-CAD patients The results of the above examinations will be used as the examination results of the case group of the present IR-CAD case-control study While patients in the control group of the present case-control study will undergo similar examinations after enrollment according to the protocol of the present case-control study
The information regarding the baseline characteristics and the examination results including demographics clinical features lab results imaging findings and prior treatment will be collected and compared between the case group and the control group
The primary endpoint is the rate of elevated erythrocyte sedimentation rate ESR
Eligible patients will be enrolled in the case group and the control group with a 21 ratio The primary endpoint of the present case-control study is elevated erythrocyte sedimentation rate ESR which is defined as ESR 15 mm for male or ESR 20 mm for female In case of normal ESR prior use of immunosuppressive therapy or prior diagnosis of autoimmune diseases before enrollment is regarded as the equivalent to elevated ESR Based on currently available data from the IR-CAD cohort study the rate of elevated ESR in the case group IR-CAD patients is 889 89 The investigators hypothesize that the rate of elevated ESR in the control group AS-CAD patients is 20 In consequence 20 patients in the case group and 10 patients in the control group would be required to test the difference of the rate of the primary endpoint between the two groups at a significance level of 005 α 005 with a power of 90 β 010 and a drop-out rate of 20
Continuous variables will be presented as mean standard deviation SD or median interquartile range IQR and compared with two-sample t-test or Wilcoxon rank sum test as appropriate Categorical data will be demonstrated as n and compared using Chi-square test or Fishers exact test as appropriate
The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics clinical features lab results imaging findings and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD
The first 20 patients who were enrolled in the IR-CAD cohort study which included patients who met the inclusionexclusion criteria for IR-CAD and received comprehensive treatment will be enrolled in the case group of the present IR-CAD case-control study Patients were diagnosed as IR-CAD if they have 1 evidence of rapidly progressive occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization myocardial ischemia typical symptoms and non-invasive evidence despite standard treatment for secondary prevention of AS-CAD 2 angiographic evidence of new coronary lesions de novo stenosis or restenosis considered to be relevant to myocardial ischemia 3 evidence of inflammation positive inflammation markers or established diagnosis of inflammatory diseases or use of immunosuppressive therapy The comprehensive treatment for IR-CAD included 1 intensified secondary prevention of AS-CAD 2 immunosuppressive therapy 3 coronary revascularization 4 supportive therapies
Patients who fulfill the inclusionexclusion criteria for AS-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study Patients will be diagnoses as AS-CAD if they 1 are 45 but 65 years of age 2 are receiving standard treatment for secondary prevention of AS-CAD after the last PCI which was performed 126 months ago 3 do not have evidence of rapidly progressive occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI myocardial ischemia typical symptoms and non-invasive evidence 4 do not have angiographic evidence of new coronary lesions de novo stenosis or restenosis considered to be relevant to myocardial ischemia
Patients in the IR-CAD cohort study underwent examinations after they met the inclusionexclusion criteria for IR-CAD based on a protocol specifically designed for the clinical management of IR-CAD patients The results of the above examinations will be used as the examination results of the case group of the present IR-CAD case-control study While patients in the control group of the present case-control study will undergo similar examinations after enrollment according to the protocol of the present case-control study
The information regarding the baseline characteristics and the examination results including demographics clinical features lab results imaging findings and prior treatment will be collected and compared between the case group and the control group
The primary endpoint is the rate of elevated erythrocyte sedimentation rate ESR
Eligible patients will be enrolled in the case group and the control group with a 21 ratio The primary endpoint of the present case-control study is elevated erythrocyte sedimentation rate ESR which is defined as ESR 15 mm for male or ESR 20 mm for female In case of normal ESR prior use of immunosuppressive therapy or prior diagnosis of autoimmune diseases before enrollment is regarded as the equivalent to elevated ESR Based on currently available data from the IR-CAD cohort study the rate of elevated ESR in the case group IR-CAD patients is 889 89 The investigators hypothesize that the rate of elevated ESR in the control group AS-CAD patients is 20 In consequence 20 patients in the case group and 10 patients in the control group would be required to test the difference of the rate of the primary endpoint between the two groups at a significance level of 005 α 005 with a power of 90 β 010 and a drop-out rate of 20
Continuous variables will be presented as mean standard deviation SD or median interquartile range IQR and compared with two-sample t-test or Wilcoxon rank sum test as appropriate Categorical data will be demonstrated as n and compared using Chi-square test or Fishers exact test as appropriate
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