Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-01 @ 11:57 PM
Study NCT ID:
NCT02494557
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients
Sponsor:
Acarix
Organization:
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:
False
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?: