Clinical trial NCT02494557: Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients
Official title: Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Arteriosclerosis
Lead sponsor: Acarix
Sponsor class: INDUSTRY
Collaborators: name: Steno Diabetes Center Copenhagen
name: Rigshospitalet, Denmark
First posted: 2015-07-10
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic type 2 patient

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acoustic Cad-score
timeFrame: 1 year
Secondary outcomes:
measure: The degree of presence of coronary artery disease (CAD) in Diabetic type 2 patients (DB2) patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
Study officials:
affiliation: Steno Diabetes Center, Niels Steensensvej 4, 2840 Gentofte, Denmark
name: Peter Rossing, Professor
role: PRINCIPAL_INVESTIGATOR
References: