Angina PectorisDan-NICAD 3NCT04707859
Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 3
An observational study of Angina Pectoris and Atherosclerosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
In a cohort of symptomatic patients referred to coronary computed tomography angiography (CCTA), the investigators aim is: 1. To investigate and compare the diagnostic precision of Rubidium Positron Emission Tomography (Rb PET) and 15O-water PET (15O-water PET) in patients where CCTA does not exclude obstructive… Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Angina Pectoris, Atherosclerosis, Coronary Artery Disease
- What is being tested?
- Head to head comparison: Rubidium vs 15O-water PET
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2021to 5 Jan 2023
- 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 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an indication for CCTA.
- Inclusion Criteria:
Patients with an indication for CCTA. Qualified patients who have signed a written informed consent form.
- Exclusion Criteria:
Demography and co-existing cardiac morbidity specific: Age below 30 years, patients having a donor heart, a mechanic heart, or mechanical heart pump, suspicion acute coronary syndrome or previous revascularization.
CCTA: Pregnant women, including women who are potentially pregnant or lactating, reduced kidney function, with an estimated glomerular filtration rate (eGFR) < 40 mL/min or allergy to X-ray contrast medium.
PET: contra-indication for adenosine (severe asthma, advanced atrioventricular block, or critical aorta stenosis).
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Gødstrup Hospital
Herning, 7400
Simon Winther, MD, PhD, simwin@rm.dk
About this study
In a cohort of symptomatic patients referred to coronary computed tomography angiography (CCTA), the investigators aim is:
- To investigate and compare the diagnostic precision of Rubidium Positron Emission Tomography (Rb PET) and 15O-water PET (15O-water PET) in patients where CCTA does not exclude obstructive coronary artery disease (CAD) using invasive coronary angiography with fractional flow reserve (ICA-FFR) as reference standard.
- To study the diagnostic accuracy and prognostic value of computed tomography fractional flow reserve (CT-FFR) in patients where CCTA does not exclude obstructive CAD with ICA-FFR as reference standard.
- To validated a pre-test probability model including genetic and circulating biomarkers.
- To identify and characterize genetic risk variants and circulating biomarkers importance in developing CAD.
- To evaluate the bone mineral density in the hip and spine and correlate this to the degree of vascular calcification.
Read the detailed description
CCTA has become the preferred diagnostic modality for symptomatic patients with low to intermediate risk of CAD. Of the patients examined, CCTA exclude cardiovascular disease in 70-80% with an excellent negative predictive value of more than 95%. Having a low positive predictive value, however, CCTA often overestimates the severity of CAD, especially in patients with moderate to severe coronary calcification. Following CCTA, patients are hence unnecessarily tested using golden standard ICA-FFR. These ICAs often show no obstructive coronary stenosis and are therefore not followed by revascularization. The issues outlined raises the question of whether it is possible (1) to make a more precise risk stratification and consequently better selection of patients prior to CCTA and (2) to reduce the number of patients referred for unnecessary ICAs following CCTA.
In patients with suspicion of coronary stenosis detected by CCTA, current guidelines recommend verification of myocardial ischemia. Dan-NICAD 3 investigate the diagnostic accuracy of advanced non-invasive myocardial perfusion imaging tests; Rb PET and 15O-water PET. These examinations have shown a high diagnostic accuracy in symptomatic patients with high risk of ischemic heart disease. However, the diagnostic accuracy is not investigated in patients as follow-up after CCTA. In addition, microcirculation may impact the correlation between PET and ICA-FFR which this study will investigate further.
An alternative way to increase the diagnostic accuracy of CCTA and thus avoid unnecessary downstream testing using ICA is to utilize the ability to extract physiological information from the anatomical CCTA images. CT-FFR has in previous studies shown promising results. In addition, calculated estimation of microcirculatiory function is under development and this study will validated these algorithms. Furthermore, the prognostic value of CT-FFR is unknown and will be tested in the pooled cohort of Dan-NICAD 1, 2 and 3.
Obtained during ICA, quantitative flow ratio (QFR) is a novel wire-free approach for fast computation of FFR with potential to increase the global use of physiological lesion assessment. QFR is superior to traditional assessment of intermediate coronary lesions based on quantitative coronary analysis of ICA. However, disagreement between ICA-FFR and QFR has been identified in up to 20% of all measurements. QFR will be validated compared to PET and ICA-FFR.
- Being tested
- Head to head comparison: Rubidium vs 15O-water PET
- Keywords
- Positron Emission Tomography, Coronary Computed Tomography Angiography, Rubidium, 15O water, Fractional flow reserve
- Medical subject headings
- Angina Pectoris, Atherosclerosis, Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head to head comparison: Rubidium vs 15O-water PETDiagnostic test
Head to head comparison with invasive FFR as reference. Adjustment for abnormal microcirculation
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Participants consenting to the study will undergo:
a1) An interview a2) Blood samples withdrawals a3) ECG a4) Non-enhanced CT a5) CCTA a6) Follow-up for > 10 years
Patients with suspicion of coronary stenosis detected by CCTA will after undergo:
b1) Rb PET b2) 15O-water PET b3) Invasive coronary angiography with 3 vessel measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) Receives: Diagnostic Test: Head to head comparison: Rubidium vs 15O-water PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Rb PET and 15-O PET
Head-to-head comparison using ICA-FFR as reference standard stratified for CFR
Measured: ICA: 4 weeks after inclusion
Secondary outcomes (8)
Diagnostic accuracy of QFR vs. ICA-FFR
Head-to-head comparison using ICA-FFR as reference standard
Measured: ICA: 4 weeks after inclusion
Pre-test probability model of CAD
Advanced pre-test probability model of CAD included clinical information, genetic and circulating biomarkers
Measured: ICA: 4 weeks after inclusion
Diagnostic accuracy of QFR
Head-to-head comparison using ICA-FFR as reference standard
Measured: ICA: 4 weeks after inclusion
Diagnostic accuracy of CT-FFR
Head-to-head comparison with PET using ICA-FFR as reference standard
Measured: ICA: 4 weeks after inclusion
Effect of reduced myocardial perfusion defect on symptoms of angina pectoris
12 months re-PET investigation will by used for estimation of reduction of myocardial perfusion defect size which will be correlated with symptoms of angina pectoris 3 and 12 mdr. after ICA
Measured: Re-PET: 12 months after inclusion
Prognostic value of clinical, biomarker, genetic information
Prognotic models will be developed based on machine learning algorithms
Measured: Follow-up: Myocardial infarction and mortality rates after 3+5+10 years
Prognostic value of clinical markers, CCTA, Rb PET, 15O-water PET, CT-FFR and QFR
Prognotic models will be developed based on machine learning algorithms
Measured: Follow-up: Myocardial infarction and mortality rates after 3+5+10 years
Predictive models of obstructive CAD
Development of pre-test probability models of obstructive CAD at ICA
Measured: ICA: 4 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start5 Jan 2021
- Primary completion5 Jul 2022 (estimated)
- Study completion5 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Winther, MD, PhD, Principal investigator, Hospital Unit West, Herning, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707859
- Sponsor's protocol ID
- Dan-NICAD 3
- Acronym
- Dan-NICAD 3
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nissen L, Winther S, Isaksen C, Ejlersen JA, Brix L, Urbonaviciene G, Frost L, Madsen LH, Knudsen LL, Schmidt SE, Holm NR, Maeng M, Nyegaard M, Botker HE, Bottcher M. Danish study of Non-Invasive testing in Coronary Artery Disease (Dan-NICAD): study protocol for a randomised controlled trial. Trials. 2016 May 26;17(1):262. doi: 10.1186/s13063-016-1388-z.
PubMed 27225018Rasmussen LD, Winther S, Westra J, Isaksen C, Ejlersen JA, Brix L, Kirk J, Urbonaviciene G, Sondergaard HM, Hammid O, Schmidt SE, Knudsen LL, Madsen LH, Frost L, Petersen SE, Gormsen LC, Christiansen EH, Eftekhari A, Holm NR, Nyegaard M, Chiribiri A, Botker HE, Bottcher M. Danish study of Non-Invasive testing in Coronary Artery Disease 2 (Dan-NICAD 2): Study design for a controlled study of diagnostic accuracy. Am Heart J. 2019 Sep;215:114-128. doi: 10.1016/j.ahj.2019.03.016. Epub 2019 May 1.
PubMed 31323454Rasmussen 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 41913985Westra 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 40887988Rasmussen 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 40590244Winther S, Rasmussen LD, Karim SR, Westra J, Dahl JN, Soby JH, Nissen L, Lomstein FB, Wurtz M, Sundboll JM, Ejlersen JA, Mortensen J, Tolbod LP, Sondergaard HM, Hansson NCL, Nyegaard M, Jensen RV, Madsen MA, Christiansen EH, Gormsen LC, Bottcher M. Myocardial Perfusion Imaging With PET: A Head-to-Head Comparison of 82Rubidium Versus 15O-water Tracers Using Invasive Coronary Measurements as Reference. Circ Cardiovasc Imaging. 2025 Jun;18(6):e017479. doi: 10.1161/CIRCIMAGING.124.017479. Epub 2025 Apr 3.
PubMed 40177753Brix 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 39788470Rasmussen LD, Westra J, Karim SR, Dahl JN, Soby JH, Ejlersen JA, Gormsen LC, Eftekhari A, Christiansen EH, Bottcher M, Winther S. Microvascular resistance reserve: impact on health status and myocardial perfusion after revascularization in chronic coronary syndrome. Eur Heart J. 2025 Feb 3;46(5):424-435. doi: 10.1093/eurheartj/ehae604.
PubMed 39217607Rasmussen LD, Karim SR, Westra J, Nissen L, Dahl JN, Brix GS, Knuuti J, Schmidt SE, Holm NR, Christiansen EH, Eftekhari A, Bottcher M, Winther S. Clinical Likelihood Prediction of Hemodynamically Obstructive Coronary Artery Disease in Patients With Stable Chest Pain. JACC Cardiovasc Imaging. 2024 Oct;17(10):1199-1210. doi: 10.1016/j.jcmg.2024.04.015. Epub 2024 Jul 3.
PubMed 38970593Winther S, Dupont Rasmussen L, Westra J, Abdulzahra SRK, Dahl JN, Gormsen LC, Christiansen EH, Brix GS, Mortensen J, Ejlersen JA, Sondergaard HM, Hansson NCL, Holm NR, Knudsen LL, Eftekhari A, Moller PL, Rohde PD, Nyegaard M, Bottcher M. Danish study of Non-Invasive Testing in Coronary Artery Disease 3 (Dan-NICAD 3): study design of a controlled study on optimal diagnostic strategy. Open Heart. 2023 Jul;10(2):e002328. doi: 10.1136/openhrt-2023-002328.
PubMed 37487656
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 3
- ClinicalTrials.gov ID
- NCT04707859
- Acronym / sponsor ID
- Dan-NICAD 3 / Dan-NICAD 3
- Keywords
- Positron Emission Tomography, Coronary Computed Tomography Angiography, Rubidium, 15O water, Fractional flow reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 Jul 2022 (estimated)
- Study completion
- 5 Jan 2023 (estimated)
- First posted
- 13 Jan 2021 (actual)
- 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.
In a cohort of symptomatic patients referred to coronary computed tomography angiography (CCTA), the investigators aim is:
- To investigate and compare the diagnostic precision of Rubidium Positron Emission Tomography (Rb PET) and 15O-water PET (15O-water PET) in patients where CCTA does not exclude obstructive coronary artery disease (CAD) using invasive coronary angiography with fractional flow reserve (ICA-FFR) as reference standard.
- To study the diagnostic accuracy and prognostic value of computed tomography fractional flow reserve (CT-FFR) in patients where CCTA does not exclude obstructive CAD with ICA-FFR as reference standard.
- To validated a pre-test probability model including genetic and circulating biomarkers.
- To identify and characterize genetic risk variants and circulating biomarkers importance in developing CAD.
- To evaluate the bone mineral density in the hip and spine and correlate this to the degree of vascular calcification.
Detailed description
CCTA has become the preferred diagnostic modality for symptomatic patients with low to intermediate risk of CAD. Of the patients examined, CCTA exclude cardiovascular disease in 70-80% with an excellent negative predictive value of more than 95%. Having a low positive predictive value, however, CCTA often overestimates the severity of CAD, especially in patients with moderate to severe coronary calcification. Following CCTA, patients are hence unnecessarily tested using golden standard ICA-FFR. These ICAs often show no obstructive coronary stenosis and are therefore not followed by revascularization. The issues outlined raises the question of whether it is possible (1) to make a more precise risk stratification and consequently better selection of patients prior to CCTA and (2) to reduce the number of patients referred for unnecessary ICAs following CCTA.
In patients with suspicion of coronary stenosis detected by CCTA, current guidelines recommend verification of myocardial ischemia. Dan-NICAD 3 investigate the diagnostic accuracy of advanced non-invasive myocardial perfusion imaging tests; Rb PET and 15O-water PET. These examinations have shown a high diagnostic accuracy in symptomatic patients with high risk of ischemic heart disease. However, the diagnostic accuracy is not investigated in patients as follow-up after CCTA. In addition, microcirculation may impact the correlation between PET and ICA-FFR which this study will investigate further.
An alternative way to increase the diagnostic accuracy of CCTA and thus avoid unnecessary downstream testing using ICA is to utilize the ability to extract physiological information from the anatomical CCTA images. CT-FFR has in previous studies shown promising results. In addition, calculated estimation of microcirculatiory function is under development and this study will validated these algorithms. Furthermore, the prognostic value of CT-FFR is unknown and will be tested in the pooled cohort of Dan-NICAD 1, 2 and 3.
Obtained during ICA, quantitative flow ratio (QFR) is a novel wire-free approach for fast computation of FFR with potential to increase the global use of physiological lesion assessment. QFR is superior to traditional assessment of intermediate coronary lesions based on quantitative coronary analysis of ICA. However, disagreement between ICA-FFR and QFR has been identified in up to 20% of all measurements. QFR will be validated compared to PET and ICA-FFR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Diagnostic Test: Head to head comparison: Rubidium vs 15O-water PETParticipants consenting to the study will undergo: a1) An interview a2) Blood samples withdrawals a3) ECG a4) Non-enhanced CT a5) CCTA a6) Follow-up for > 10 years Patients with suspicion of coronary stenosis detected by CCTA will after undergo: b1) Rb PET b2) 15O-water PET b3) Invasive coronary angiography with 3 vessel measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for CCTA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head to head comparison: Rubidium vs 15O-water PETHead to head comparison with invasive FFR as reference. Adjustment for abnormal microcirculation | Diagnostic test | Cohort |
Primary outcome
Diagnostic accuracy of Rb PET and 15-O PET
Time frame: ICA: 4 weeks after inclusion
Head-to-head comparison using ICA-FFR as reference standard stratified for CFR
8 secondary outcomes
Diagnostic accuracy of QFR vs. ICA-FFR
Time frame: ICA: 4 weeks after inclusion
Pre-test probability model of CAD
Time frame: ICA: 4 weeks after inclusion
Diagnostic accuracy of QFR
Time frame: ICA: 4 weeks after inclusion
Diagnostic accuracy of CT-FFR
Time frame: ICA: 4 weeks after inclusion
Effect of reduced myocardial perfusion defect on symptoms of angina pectoris
Time frame: Re-PET: 12 months after inclusion
Prognostic value of clinical, biomarker, genetic information
Time frame: Follow-up: Myocardial infarction and mortality rates after 3+5+10 years
Prognostic value of clinical markers, CCTA, Rb PET, 15O-water PET, CT-FFR and QFR
Time frame: Follow-up: Myocardial infarction and mortality rates after 3+5+10 years
Predictive models of obstructive CAD
Time frame: ICA: 4 weeks after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Background: PubMed 27225018Nissen L, Winther S, Isaksen C, Ejlersen JA, Brix L, Urbonaviciene G, Frost L, Madsen LH, Knudsen LL, Schmidt SE, Holm NR, Maeng M, Nyegaard M, Botker HE, Bottcher M. Danish study of Non-Invasive testing in Coronary Artery Disease (Dan-NICAD): study protocol for a randomised controlled trial. Trials. 2016 May 26;17(1):262. doi: 10.1186/s13063-016-1388-z.
- Background: PubMed 31323454Rasmussen LD, Winther S, Westra J, Isaksen C, Ejlersen JA, Brix L, Kirk J, Urbonaviciene G, Sondergaard HM, Hammid O, Schmidt SE, Knudsen LL, Madsen LH, Frost L, Petersen SE, Gormsen LC, Christiansen EH, Eftekhari A, Holm NR, Nyegaard M, Chiribiri A, Botker HE, Bottcher M. Danish study of Non-Invasive testing in Coronary Artery Disease 2 (Dan-NICAD 2): Study design for a controlled study of diagnostic accuracy. Am Heart J. 2019 Sep;215:114-128. doi: 10.1016/j.ahj.2019.03.016. Epub 2019 May 1.
- Derived from this study: PubMed 41913985Rasmussen 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.
- Derived from this study: PubMed 40887988Westra 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.
- Derived from this study: PubMed 40590244Rasmussen 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.
- Derived from this study: PubMed 40177753Winther S, Rasmussen LD, Karim SR, Westra J, Dahl JN, Soby JH, Nissen L, Lomstein FB, Wurtz M, Sundboll JM, Ejlersen JA, Mortensen J, Tolbod LP, Sondergaard HM, Hansson NCL, Nyegaard M, Jensen RV, Madsen MA, Christiansen EH, Gormsen LC, Bottcher M. Myocardial Perfusion Imaging With PET: A Head-to-Head Comparison of 82Rubidium Versus 15O-water Tracers Using Invasive Coronary Measurements as Reference. Circ Cardiovasc Imaging. 2025 Jun;18(6):e017479. doi: 10.1161/CIRCIMAGING.124.017479. Epub 2025 Apr 3.
- Derived from this study: PubMed 39788470Brix 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.
- Derived from this study: PubMed 39217607Rasmussen LD, Westra J, Karim SR, Dahl JN, Soby JH, Ejlersen JA, Gormsen LC, Eftekhari A, Christiansen EH, Bottcher M, Winther S. Microvascular resistance reserve: impact on health status and myocardial perfusion after revascularization in chronic coronary syndrome. Eur Heart J. 2025 Feb 3;46(5):424-435. doi: 10.1093/eurheartj/ehae604.
- Derived from this study: PubMed 38970593Rasmussen LD, Karim SR, Westra J, Nissen L, Dahl JN, Brix GS, Knuuti J, Schmidt SE, Holm NR, Christiansen EH, Eftekhari A, Bottcher M, Winther S. Clinical Likelihood Prediction of Hemodynamically Obstructive Coronary Artery Disease in Patients With Stable Chest Pain. JACC Cardiovasc Imaging. 2024 Oct;17(10):1199-1210. doi: 10.1016/j.jcmg.2024.04.015. Epub 2024 Jul 3.
- Derived from this study: PubMed 37487656Winther S, Dupont Rasmussen L, Westra J, Abdulzahra SRK, Dahl JN, Gormsen LC, Christiansen EH, Brix GS, Mortensen J, Ejlersen JA, Sondergaard HM, Hansson NCL, Holm NR, Knudsen LL, Eftekhari A, Moller PL, Rohde PD, Nyegaard M, Bottcher M. Danish study of Non-Invasive Testing in Coronary Artery Disease 3 (Dan-NICAD 3): study design of a controlled study on optimal diagnostic strategy. Open Heart. 2023 Jul;10(2):e002328. doi: 10.1136/openhrt-2023-002328.
- Individual participant dataSharing planned: No
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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.
Simon Winther, MD, PhD principal investigator
Hospital Unit West, Herning, 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 Angina Pectoris and Atherosclerosis, run by University of Aarhus 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?
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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Winther, MD, PhD (78430000, simwin@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of Rb PET and 15-O PET (time frame: ICA: 4 weeks after inclusion). 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 NCT04707859, which also lists 10 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 29 Jan 2021.