Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients

NCT ID: NCT02494557

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-03-31

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.

Conditions

Coronary Arteriosclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Acarix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Rossing, Professor

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center, Niels Steensensvej 4, 2840 Gentofte, Denmark

Locations

Steno Diabetes Center

Gentofte Municipality, , Denmark

Countries

Denmark

Other Identifiers

CAD-risk/2014

Identifier Type: -

Identifier Source: org_study_id