Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients
CAD-risk
1 other identifier
observational
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 8, 2015
CompletedFirst Posted
Study publicly available on registry
July 10, 2015
CompletedMay 23, 2017
May 1, 2017
6 months
July 8, 2015
May 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (1)
The degree of presence of coronary artery disease (CAD) in Diabetic type 2 patients (DB2) patients
1 year
Eligibility Criteria
Diabetic type 2 patient
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acarixlead
- Steno Diabetes Center Copenhagencollaborator
- Rigshospitalet, Denmarkcollaborator
Study Sites (1)
Steno Diabetes Center
Gentofte Municipality, 2840, Denmark
Biospecimen
Blood samples for biobank to be used in potential new studies.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Rossing, Professor
Steno Diabetes Center, Niels Steensensvej 4, 2840 Gentofte, Denmark
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2015
First Posted
July 10, 2015
Study Start
September 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 23, 2017
Record last verified: 2017-05