Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients

Completed

• Conditions: Coronary Arteriosclerosis

• Registration Number: NCT02494557
• Lead Sponsor: Acarix

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-22
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Patients suffering from diabetes type 2
• Both sexes
• Patients between 40 and 80 years
• Patients without chest pain at rest and labor
• Patients having a normal electrocardiogram (ECG, i.e. without Q-peaks/ T-peak abnormalities in sinus rhythm)
• Patients having intact skin over sternum

Exclusion Criteria

• Patients suffering from a heart disease
• Patients already having received heart surgery
• Patients with pacemaker or other implanted electronic device
• Patients suffering from allergy against iodine and iodine containing substances
• Patients with estimated GFR below 50 ml/min/1.73 sqm m
• Patients suffering from adenosine intolerance or known allergic asthma
• Patients not being capable of understanding the patient information of the study
• Patients who are pregnant
• Patients suffering from allergy to adhesives

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acoustic Cad-score	1 year	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

Secondary Outcome Measures

Name	Time	Method
The degree of presence of coronary artery disease (CAD) in Diabetic type 2 patients (DB2) patients	1 year	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.

Trial Locations

Locations (1)

Steno Diabetes Center; 🇩🇰 Gentofte, Denmark