Ignite Creation Date:
2024-05-06 @ 12:26 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01578876
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2012-02-19
Brief Title:
Extracorporeal Cardiac Shock Wave Therapy CSWT for Treatment of Coronary Artery Disease
Sponsor:
Kunming Medical University
Organization:
Kunming Medical University
Study Overview
Official Title:
To Prove up the Effect of CSWT in Vivo and to Evaluate the Feasibility and Efficiency of CSWT for Treatment of CAD and to Establish the Inclusion and Exclusion Criteria and Summarize the Methodological Outlines of CSWT in China
Status:
COMPLETED
Status Verified Date:
2012-04
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 purpose of this study is to determine the effectiveness of cardiac shock wave therapy CSWT for the treatment of severe coronary artery disease CAD in a Chinese cohort
Detailed Description:
This study was approved by the Institutional Review Board and Ethics Committee of 1st Hospital of Kunming Medical University and all study subjects signed informed consent for participation in the study and all treatments performed Subjects were patients who were hospitalized at Department of Cardiology of our hospital from December 2008 to December 2009
Patients were eligible to be included in the study if they met any of the following criteria 1 Coronary angiography CA or multi-slice CT coronary angiography CTCA suggestive of moderate to severe coronary artery stenosis 2 Chest tightness onset of shortness of breath and poor exercise tolerance after receiving formal drug treatment with or without stent or bypass graft 3 Hospitalized more than 2 times within 1 year due to the aforementioned problems 4 CCS angina grading higher than grade II and NYHA functional classification of I-III 5 More than 1 month after acute myocardial infarction AMI and more than 2 weeks after PCI surgery The diagnosis and treatment in all the patients was in accordance with the related domestic and European guidelines developed in 2007
Patients were eligible to be included in the study if they met any of the following criteria 1 Coronary angiography CA or multi-slice CT coronary angiography CTCA suggestive of moderate to severe coronary artery stenosis 2 Chest tightness onset of shortness of breath and poor exercise tolerance after receiving formal drug treatment with or without stent or bypass graft 3 Hospitalized more than 2 times within 1 year due to the aforementioned problems 4 CCS angina grading higher than grade II and NYHA functional classification of I-III 5 More than 1 month after acute myocardial infarction AMI and more than 2 weeks after PCI surgery The diagnosis and treatment in all the patients was in accordance with the related domestic and European guidelines developed in 2007
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None