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Angina PectorisNCT02264717

Dan-NICAD - Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease

A study testing SPECT and Cardiac MRI in people with Angina Pectoris and Arteriosclerosis, run by University of Aarhus at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. The primary purpose of this study is to determine the diagnostic accuracy of the CADscore System, a new danish technology that records sounds from turbulence of bloodflow in the coronary vessels. And secondary: 1. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
SPECT and Cardiac MRI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,676 participants
Where
3 sitesDenmark
Study dates
Sep 2014to May 2016
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Indication for Cardiac CT
  • Signed

Who cannot join

  • Age under 40
  • Pregnant, potentially pregnant or breast feeding
  • Contraindication for adenosine (severe asthma, clinical aortic stenosis)
  • Reduced kidney function (eGFR < 40 ml/min)
  • Contraindication for MRI
  • Previous history of allergy to contrast
  • Previous revascularisation procedure

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Aarhus University Hospital

    Aarhus, Central Jutland, 8200

  • Regional Hospital of Herning

    Herning, Central Jutland, 7400

  • Regional Hospital of Silkeborg

    Silkeborg, Central Jutland, 8600

Other trials in Denmark

About this study

  1. The primary purpose of this study is to determine the diagnostic accuracy of the CADscore System, a new danish technology that records sounds from turbulence of bloodflow in the coronary vessels.

And secondary:

  1. To determine the accuracy of cardiac magnetic resonance imaging (MRI) and single-photon emission computed tomography (SPECT), as secondary tests after detection of obstructive anatomic coronary artery stenosis by coronary computed tomographic angiography (CCTA).
  2. To examine the patient population for bio-genetic markers related to development of arteriosclerosis.
  3. To evaluate virtual fractional flow reserve (vFFR) computed from coronary angiograms.
Read the detailed description

Primary study CCTA is currently the first choice to rule out coronary artery disease (CAD) in patients with typical or atypical chest pain. 4500 patients are annually examined with CCTA, in the Central Jutland Region of Denmark, and approximately 80% are discharged after ruling out CAD. CCTA is a diagnostic scan that exposes the patients to radiation, therefore a better risk stratification prior to the test is desirable. The CADscore is a newly developed danish technology that has been tested so far in 1000 patients. An area under the curve of the receiver operating characteristic (AUC of ROC) of 75-80 has been determined compared to conventional coronary angiography using quantitative coronary angiography (CCA-QCA). This indicates that the CADscore could potentially be used to diagnose CAD as a supplement or risk stratification prior to CCTA.

We aim to evaluate the CADscore in a large clinical trial including 2000 patients that by clinical indication undergo cCTA. After cCTA approximately 20 % (400 patients) will need evaluation by CCA with FFR. CADscore results will be compared to CCTA and CCA-QCA. Secondary, the CADscore will be compared to the results of CCA-FFR and perfusion scans, Cardiac-MRI and SPECT.

Substudies

  1. Perfusion scans CCTA demonstrates good diagnostic performance for detection and exclusion of anatomic coronary artery stenosis, but several studies have previously shown that CCTA has a low positive predictive value for identification of hemodynamically significant CAD. This emphasizes the need for additional tests to evaluate the severity (or exclusion) of hemodynamically significant CAD. Measurement of FFR during CCA represents the "gold standard" for assessment of the hemodynamic significance of coronary artery stenosis. The disadvantage of CCA with FFR is that it is an invasive procedure. After cCTA approximately 20 % (400 patients) will need further testing and that group of patients will be randomized to either Cardiac MRI or SPECT followed by CCA with FFR. The substudy aims to evaluate the diagnostic accuracy of perfusion imaging (Cardiac MRI and SPECT) compared with CCA with FFR.
  2. Virtual FFR

The accuracy and precision of virtual-FFR compared with conventional FFR will be determined. Virtual FFR is computed from the coronary angiogram using computational fluid dynamics. Subjects with diameter stenosis in the range of 30 to 90% by visual estimate in one or more vessel segments with reference diameter ≥2.0 mm will be included in the analysis. FFR is the reference standard to determine the presence or absence of hemodynamically significant obstruction with a cut-off value of 0.80. Computation of vFFR with and without hyperaemia will be compared.

Being tested
SPECT, Cardiac MRI
Medical subject headings
Angina Pectoris, Arteriosclerosis, Coronary Artery Disease, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPECTProcedure or surgery

    Patients are randomized to either SPECT or Cardiac MRI

  • Cardiac MRIProcedure or surgery

    Patients are randomized to either SPECT or Cardiac MR

Study groups in NCT02264717
Study groupRoleWhat they receive
Cardiac MRiActive comparatorA minimum of 150 patients will be randomized to Cardiac MRI followed by conventional angiography CCA-FFR, after detection of obstructive anatomic coronary artery stenoses on coronary Computed Tomography Angiography (cCTA)
Receives: Procedure: Cardiac MRI
SPECTActive comparatorA minimum 150 patients will be randomized to SPECT followed by conventional angiography CCA-FFR, after detection of obstructive anatomic coronary artery stenoses on coronary Computed Tomography Angiography (cCTA).
Receives: Procedure: SPECT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy of the CADscore system compared to CCTA and CCA-QCA.

    Diagnostic precision will be evaluated as the AUC-ROC. The CADscore will be dichotomized at cut off values of 20,25 and 30 and performance reported with sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy. The CADscore system operates with 3 intervals of risk stratification: <20, 20-30, >30 (low, intermedia and high risk of cardio vascular disease, respectively) Obstructive CAD is defined as ≥ 50% diameter stenosis as determined by quantitative analysis of CCA (QCA). Non-Obstructive CAD is defined as no detection of obstructive anatomic coronary artery stenosis by CCTA or stenosis detected by CCTA combined with a evaluation by CCA-QCA demonstrating a luminal stenosis diameter < 50 %.

    Measured: Within one week before or after CCTA

Secondary outcomes (2)

  1. Safety of CADScore Safety of CADScore

    Registration of adverse events related to the use of CADScore

    Measured: One week after the use of CADScore

  2. Diagnostic accuracy of the CADScore system compared to CCA-FFR.

    Diagnostic precision will be evaluated as the AUC-ROC and performance reported with sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy.

    CAD is defined as CCA-FFR under 0.80.

    Measured: Within four weeks after CADScore

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
1,676 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02264717
Sponsor's protocol ID
Dan-NICAD
Status last verified
May 2015
First submitted
26 Sep 2014
Last updated
13 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Rasmussen LD, Hoek R, Westra J, Soby JH, Maaniitty T, Braathen AT, Saraste A, Isaksen C, Nissen L, Petersen SE, Aakhus S, Knaapen P, Gormsen LC, Christiansen EH, Knuuti JM, Bottcher M, Driessen RS, Winther S. Diagnostic yield of second-line functional imaging after an abnormal coronary computed tomography angiography: an individual patient-data meta-analysis. Eur Heart J Cardiovasc Imaging. 2026 Jun 1;27(6):1176-1189. doi: 10.1093/ehjci/jeag088.

    PubMed 41913985

  • Westra J, Rasmussen LD, Karim SR, Jensen RV, Ejlersen JA, Gormsen LC, Bottcher M, Eftekhari A, Winther S, Christiansen EH. Coronary microvascular disease in patients referred to coronary angiography following coronary computed tomography angiography. EuroIntervention. 2025 Sep 1;21(17):e1005-e1014. doi: 10.4244/EIJ-D-24-01155.

    PubMed 40887988

  • Rasmussen LD, Sikjaer M, Soby JH, Pedersen OB, Westra J, Efthekhari A, Christiansen EH, Foldyna B, Williams MC, Dweck MR, Newby DE, Douglas PS, Bottcher M, Winther S. Dual probability approach for risk adjustment in patients with a low clinical likelihood of coronary artery disease. Eur Heart J Cardiovasc Imaging. 2025 Aug 29;26(9):1507-1517. doi: 10.1093/ehjci/jeaf193.

    PubMed 40590244

  • Brix GS, Rasmussen LD, Rohde PD, Nissen L, Nyegaard M, O'Donoghue ML, Bottcher M, Winther S. Elevated lipoprotein(a) levels are independently associated with the presence of significant coronary stenosis in de-novo patients with stable chest pain. Am Heart J. 2025 Apr;282:103-113. doi: 10.1016/j.ahj.2025.01.001. Epub 2025 Jan 7.

    PubMed 39788470

  • Pedersen G, Dahl JN, Rasmussen LD, Garm Blavnsfeldt AB, Bottcher SH, Bottcher MH, Nyegaard M, Nissen L, Winther S. Biomarkers for identification of high-risk coronary artery plaques in patients with suspected coronary artery disease. J Cardiovasc Comput Tomogr. 2024 Sep-Oct;18(5):467-475. doi: 10.1016/j.jcct.2024.06.009. Epub 2024 Jul 2.

    PubMed 38955554

  • Moller PL, Rohde PD, Dahl JN, Rasmussen LD, Nissen L, Schmidt SE, McGilligan V, Gudbjartsson DF, Stefansson K, Holm H, Bentzon JF, Bottcher M, Winther S, Nyegaard M. Predicting the presence of coronary plaques featuring high-risk characteristics using polygenic risk scores and targeted proteomics in patients with suspected coronary artery disease. Genome Med. 2024 Mar 20;16(1):40. doi: 10.1186/s13073-024-01313-8.

    PubMed 38509622

  • Moller PL, Rohde PD, Dahl JN, Rasmussen LD, Schmidt SE, Nissen L, McGilligan V, Bentzon JF, Gudbjartsson DF, Stefansson K, Holm H, Winther S, Bottcher M, Nyegaard M. Combining Polygenic and Proteomic Risk Scores With Clinical Risk Factors to Improve Performance for Diagnosing Absence of Coronary Artery Disease in Patients With de novo Chest Pain. Circ Genom Precis Med. 2023 Oct;16(5):442-451. doi: 10.1161/CIRCGEN.123.004053. Epub 2023 Sep 27.

    PubMed 37753640

  • Westra J, Rasmussen LD, Eftekhari A, Winther S, Karim SR, Johansen JK, Hammid O, Sondergaard HM, Ejlersen JA, Gormsen LC, Mogensen LJH, Bottcher M, Holm NR, Christiansen EH. Coronary Artery Stenosis Evaluation by Angiography-Derived FFR: Validation by Positron Emission Tomography and Invasive Thermodilution. JACC Cardiovasc Imaging. 2023 Oct;16(10):1321-1331. doi: 10.1016/j.jcmg.2023.02.008. Epub 2023 Apr 12.

    PubMed 37052562

  • Winther S, Nissen L, Schmidt SE, Westra J, Andersen IT, Nyegaard M, Madsen LH, Knudsen LL, Urbonaviciene G, Larsen BS, Struijk JJ, Frost L, Holm NR, Christiansen EH, Botker HE, Bottcher M. Advanced heart sound analysis as a new prognostic marker in stable coronary artery disease. Eur Heart J Digit Health. 2021 Mar 19;2(2):279-289. doi: 10.1093/ehjdh/ztab031. eCollection 2021 Jun.

    PubMed 36712398

  • Christiansen MK, Winther S, Nissen L, Vilhjalmsson BJ, Frost L, Johansen JK, Moller PL, Schmidt SE, Westra J, Holm NR, Jensen HK, Christiansen EH, Guethbjartsson DF, Holm H, Stefansson K, Botker HE, Bottcher M, Nyegaard M. Polygenic Risk Score-Enhanced Risk Stratification of Coronary Artery Disease in Patients With Stable Chest Pain. Circ Genom Precis Med. 2021 Jun;14(3):e003298. doi: 10.1161/CIRCGEN.120.003298. Epub 2021 May 25.

    PubMed 34032468

  • Therkildsen J, Nissen L, Jorgensen HS, Thygesen J, Ivarsen P, Frost L, Isaksen C, Langdahl BL, Hauge EM, Boettcher M, Winther S. Thoracic Bone Mineral Density Derived from Cardiac CT Is Associated with Greater Fracture Rate. Radiology. 2020 Sep;296(3):499-508. doi: 10.1148/radiol.2020192706. Epub 2020 Jul 14.

    PubMed 32662758

  • Christiansen MK, Nissen L, Winther S, Moller PL, Frost L, Johansen JK, Jensen HK, Guethbjartsson D, Holm H, Stefansson K, Botker HE, Bottcher M, Nyegaard M. Genetic Risk of Coronary Artery Disease, Features of Atherosclerosis, and Coronary Plaque Burden. J Am Heart Assoc. 2020 Feb 4;9(3):e014795. doi: 10.1161/JAHA.119.014795. Epub 2020 Jan 25.

    PubMed 31983321

  • Winther S, Nissen L, Westra J, Schmidt SE, Bouteldja N, Knudsen LL, Madsen LH, Frost L, Urbonaviciene G, Holm NR, Christiansen EH, Botker HE, Bottcher M. Pre-test probability prediction in patients with a low to intermediate probability of coronary artery disease: a prospective study with a fractional flow reserve endpoint. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1208-1218. doi: 10.1093/ehjci/jez058.

    PubMed 31083725

  • Westra J, Tu S, Winther S, Nissen L, Vestergaard MB, Andersen BK, Holck EN, Fox Maule C, Johansen JK, Andreasen LN, Simonsen JK, Zhang Y, Kristensen SD, Maeng M, Kaltoft A, Terkelsen CJ, Krusell LR, Jakobsen L, Reiber JHC, Lassen JF, Bottcher M, Botker HE, Christiansen EH, Holm NR. Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography: The WIFI II Study (Wire-Free Functional Imaging II). Circ Cardiovasc Imaging. 2018 Mar;11(3):e007107. doi: 10.1161/CIRCIMAGING.117.007107.

    PubMed 29555835

  • Winther S, Nissen L, Schmidt SE, Westra JS, Rasmussen LD, Knudsen LL, Madsen LH, Kirk Johansen J, Larsen BS, Struijk JJ, Frost L, Holm NR, Christiansen EH, Botker HE, Bottcher M. Diagnostic performance of an acoustic-based system for coronary artery disease risk stratification. Heart. 2018 Jun;104(11):928-935. doi: 10.1136/heartjnl-2017-311944. Epub 2017 Nov 9.

    PubMed 29122932

Questions about this trial

What is this clinical trial studying?

A study testing SPECT and Cardiac MRI in people with Angina Pectoris and Arteriosclerosis, run by University of Aarhus at 3 sites 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 2 inclusion and 7 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Diagnostic accuracy of the CADscore system compared to CCTA and CCA-QCA. (time frame: Within one week before or after CCTA). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02264717, which also lists 16 linked publications.

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 13 May 2016.

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