Coronary ArteriosclerosisCAD-riskNCT02494557
Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients
An observational study of Coronary Arteriosclerosis, run by Acarix at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Coronary Arteriosclerosis
- How many people
- 108 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic type 2 patient
Who may be able to join
- 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
Who cannot join
- 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
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- Patients not being capable of understanding the patient information of the study
- Patients who are pregnant
- Patients suffering from allergy to adhesives
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acarix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Peter Rossing, Professor, Principal investigator, Steno Diabetes Center, Niels Steensensvej 4, 2840 Gentofte, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494557
- Sponsor's protocol ID
- CAD-risk/2014
- Acronym
- CAD-risk
- Status last verified
- May 2017
- First submitted
- 8 Jul 2015
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02494557
- Acronym / sponsor ID
- CAD-risk / CAD-risk/2014
- Conditions
- Coronary Arteriosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- AcarixIndustry (pharma, biotech, devices)
- Collaborators
- Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic type 2 patient
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acoustic Cad-score
Time frame: 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
1 secondary outcome
The degree of presence of coronary artery disease (CAD) in Diabetic type 2 patients (DB2) patients
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rossing, Professor principal investigator
Steno Diabetes Center, Niels Steensensvej 4, 2840 Gentofte, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arteriosclerosis, run by Acarix at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic Cad-score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.