Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02494557
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2015-07-08
Brief Title:
Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients
Sponsor:
Acarix
Organization:
Acarix
Study Overview
Official Title:
Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2017-05
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:
CAD-risk
Brief Summary:
Diabetic type 2 patients DB2 has a higher prevalence of coronary artery disease CAD than non-diabetic persons Presence of CAD results in murmurs arising from the filling of the arteries and can be detected by the CADScor System and can together with biological patient profile indicate the risk of presence of CAD in the patient In the pilot study 100 asymptomatic DB2-patients examined with CADScor System and biomarkers will be compared with computed tomography CT cardiography and single-photon emission computed tomography SPECT for assessing if combination of patient profile gender age etc combined with above measures may give rise to new improved risk scoring method for he DB2-patient
Detailed Description:
The study is intended as a pilot observational study for evaluation of a new risk scoring method CADScor System is relevant for assessment of CAD in the DB2-patient
The primary end point will be to document that the hypothesis of combining the CADScor System measure with other patient profile data will increase the accuracy of the method for determination of risk of presence of CAD
The secondary endpoint will be to show that a receiver operating characteristic curve ROC of 80 for correct determination of presence of CAD will be achieved
The further objective of the study will be to confirm the relevance of performing a large scale study with equivalent objectives
As controls in the study will be applied CT angiography CT-calcium and resting and drug induced CT-scintigraphy
It is assumed that 15-20 of enrolled patients in the study will suffer from CAD
The primary end point will be to document that the hypothesis of combining the CADScor System measure with other patient profile data will increase the accuracy of the method for determination of risk of presence of CAD
The secondary endpoint will be to show that a receiver operating characteristic curve ROC of 80 for correct determination of presence of CAD will be achieved
The further objective of the study will be to confirm the relevance of performing a large scale study with equivalent objectives
As controls in the study will be applied CT angiography CT-calcium and resting and drug induced CT-scintigraphy
It is assumed that 15-20 of enrolled patients in the study will suffer from CAD
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