An observational study in Coronary Arteriosclerosis, sponsored by Acarix. Completed at 1 site in Denmark. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-23.
Sponsored by Acarix · Observational
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 108 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Acarix is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Diabetic type 2 patient
Exclusion Criteria:
Acoustic Cad-score
Comparison of an non-invasive acoustic Cad-score as risk prediction for presence of coronary artery disease with control studies of CT-angiography and resting and drug induced CT scintigraphy
Time frame: 1 year
The degree of presence of coronary artery disease (CAD) in Diabetic type 2 patients (DB2) patients
Resting and drug induced perfusion test will be compared to CT Angiography for determining the degree of presence of CAD when including patient parameters characterizing the status and severity of the DB2.
Time frame: 1 year
Plan to share: Undecided
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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