Coronary Artery DiseaseiCORONARYNCT04939207
Safety and Cost-efficiëncy of New Imaging Techniques in Patients Suspected of Coronary Artery Disease
A study testing CT-FFR, Angiography-derived FFR and Angiography with invasive FFR-measurements in people with Coronary Artery Disease, run by St. Antonius Hospital at 4 sites in Netherlands.
Trial summary
Yearly, 180 000 patients in the Netherlands are referred to a cardiologist with symptoms suspected of coronary artery disease (CAD). To assess this, multiple diagnostic tests are available. Non-invasive imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out CAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CT-FFR, Angiography-derived FFR and Angiography with invasive FFR-measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- 4 sitesNetherlands
- Study dates
- 22 Mar 2022to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is willing and able to provide informed consent and adhere to study rules and regulations and follow-up
- The subject is clinically suspected of having (recurrent) angina pectoris or an equivalent and suspected coronary artery disease, based on symptoms and signs, history, clinical examination and baseline diagnostic testing (e.g. ECG recording and laboratory tests) as described in the 2019 ESC guideline on chronic coronary syndromes.
- The subject has had ≥64 multidetector row coronary CTA or will undergo coronary CTA as part of usual care deemed by the treating physician with ≥64 multidetector row coronary CTA.
Who cannot join
- The subject is suffering from unstable angina pectoris.
- The subject is suffering from decompensated congestive cardiac failure.
- The subject is suffering from a known non-ischemic cardiomyopathy.
- The subject has a history of PCI or CABG.
- The subject has had pacemaker or internal defibrillator leads implanted.
- The subject has a prosthetic heart valve.
Show all 16Show fewer
- There is a severe language barrier.
- The subject participates in any other clinical trial that interferes with the current study.
- Clinical condition prohibiting subsequent interventional therapy as indicated by the results of the imaging procedures.
- The subject is or might be pregnant.
- The subject does not comply or is not able to comply to the imaging guidelines for the performance and acquisition of CCTA by the Society of Cardiac Computed Tomography (SCCT), including:
- The subject is suffering from a cardiac rhythm other than sinus rhythm.
- The subject is morbidly obese (Body Mass Index (BMI) > 40).
- The subject is not able to sustain a breath-hold for 25 seconds.
- The subject is unable to remain in supine position for at least 30 minutes.
- The subject has known allergies to or contra-indications to receiving an iodinated contrast agent. Contraindications to receiving an iodinated contrast agent: Glomerular Filtration Rate (GFR) < 45 ml/min/1,73m2 and if the subject is diabetic or has at least two risk factors for developing contrast induced renal failure a GFR < 60 ml/min/1,73m2.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands4 sites, 4 recruiting
- Recruiting
Catharina Hospital
Eindhoven, North Brabant, 5623EJ
Leonie M Becker, MD, +31629642180, l.becker@antoniusziekenhuis.nl
Patrick Houthuizen, MD, PhD
- Recruiting
St. Antonius Hospital
Nieuwegein, Utrecht, 3435 CM
Leonie M Becker, MD, +31629642180, l.becker@antoniusziekenhuis.nl
Martin J Swaans, MD, PhD
- Recruiting
Maasstad Hospital
Rotterdam, South Holland, 3079DZ
Leonie M Becker, MD, +31629642180, l.becker@antoniusziekenhuis.nl
Willem van Dockum, MD, PhD
- Not yet recruiting
UMC Utrecht
Utrecht, Utrecht, 3584X
Leonie M Becker, MD, +31629642180, l.becker@antoniusziekenhuis.nl
Michiel Voskuil, MD, PhD
About this study
Official title: Improving the Cost-effectiveness of Coronary Artery Disease Diagnosis
Yearly, 180 000 patients in the Netherlands are referred to a cardiologist with symptoms suspected of coronary artery disease (CAD). To assess this, multiple diagnostic tests are available. Non-invasive imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out CAD. However, when CAD is present, coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis. Cardiac angiography with invasive blood flow measurements is required to assess this restriction in blood flow. This is an invasive test, more expensive than CT and it is accompanied by certain risks.
Most patients in whom CAD is present do not need treatment, and would therefore benefit from non-invasive diagnostic tests. To reduce the number of unnecessary cardiac angiography with flow measurements, new imaging techniques have been developed. These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment. This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan.
Read more
Subjects are eligible if their CT-scan indicates possibly significant CAD. To determine need for treatment of a subject's CAD, the investigators will randomize subjects in three arms. One arm consists of additional CT-derived calculation of coronary blood flow, one arm consists of angiography-derived calculation of coronary blood flow and one arm consists of standard care, coronary angiography and invasive coronary blood flow measurements. After these tests, subjects are treated and followed according to routine care guidelines. Additionally, subjects are requested to complete 5 questionnaires in a 12 month follow-up period.
The investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques. The investigators expect that this will lead to a reduction in healthcare costs, complications and a lower burden of diagnostic tests for patients. The investigators do not expect a difference in primary endpoints between the study groups.
Read the detailed description
Only a small proportion of the 180 000 patients that are referred to a cardiologist each year in the Netherlands with complaints of angina pectoris or shortness of breath suffer from coronary stenosis in such a degree that revascularisation is required. To identify these patients, multiple diagnostic tests are available. Simple non-interventional imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out coronary artery disease. However, when coronary artery disease is present, coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis. Cardiac angiography with invasive blood flow measurements is required to assess this restriction in blood flow. This is an invasive test, more expensive than CT and it is accompanied by certain risks.
In retrospect, many patients unnecessarily undergo cardiac angiography with, if deemed neccessary, flow measurements. These patients do not need treatment for coronary artery disease. To reduce the number of unnecessary cardiac angiography with flow measurements, new imaging techniques have been developed. These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment. These new imaging techniques have been tested extensively in observational studies. Currently, there is no consensus in the optimal diagnostic pathway resulting in major differences in strategies between hospitals. Moreover,data on cost-effectiveness is lacking.
This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan. Our target population will be patients with complaints of angina pectoris or shortness of breath for which the patients will undergo coronary CT-scan. If the CT-scan shows one or more possibly flow-limiting stenoses, further diagnostic testing is required. These subjects are randomized in one of three possible arms. One arm will receive additional CT-derived calculation of coronary blood flow, one arm will receive angiography-derived calculation of coronary blood flow and one arm will receive standard care. Standard care consists of coronary angiography and invasive coronary blood flow measurements. The results of these tests determine the need for treatment of coronary artery disease. After these tests, subjects are treated according to routine care guidelines. Subjects are requested to complete 5 questionnaires in a 12 month follow-up period. The primary endpoint is a composite of MACE - all-cause mortality, aborted sudden cardiac death, myocardial infarction and unplanned hospitalization for chest pain leading to urgent revascularization during the 12-month follow-up period. Secondary endpoints consist of cost-effectiveness, the number of avoided invasive coronary angiographies and flow measurements and quality of life. The investigators will use hospital patient files and completed questionnaires to collect information about events during the follow-up period until the last included subject has completed their final questionnaire.
The investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques. The investigators expect that this will lead to a reduction in healthcare costs, complications and a lower burden of diagnostic tests for patients. The investigators do not expect a difference in primary endpoints between the study groups.
In addition to the randomised controlled trial, all eligible subjects whose coronary CT-scan does not show possibly significant coronary artery disease (CAD-RADS 0-2) are included in a patient registry. Because of absent or limited coronary artery disease, additional diagnostic testing is not needed in these patients. These subjects are requested to answer 5 questionnaires in a 12-month period, similar to the subjects included in the RCT-part of the trial. The outcome measures of this part of the trial are similar to those of the RCT. Our primary outcome is the occurrence of MACE-events, secondary outcomes are quality of life and patient satisfaction.
- Conditions
- Coronary Artery Disease
- Being tested
- CT-FFR, Angiography-derived FFR, Angiography with invasive FFR-measurements
- Keywords
- Coronary artery disease, Angina pectoris, Coronary arteriosclerosis, CT scan, Cardiac catheterization, Coronary angiography, Myocardial fractional flow reserve
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-FFRDiagnostic test
CT-images will be processed by an algorithm to calculate FFR-values of the full coronary tree
Angiography-derived FFRDiagnostic test
FFR-values are calculated during coronary angiography based on the acquired images of the coronary arteries
Angiography with invasive FFR-measurementsDiagnostic test
during coronary angiography, a specialized pressure wire is passed through the coronary stenosis to calculate FFR based on the difference between the actual pressure and the expected pressure in the hypothetical healthy coronary artery.
| Study group | Role | What they receive |
|---|---|---|
| CT-derived FFR | Experimental | In this study arm, the need for coronary revascularization will be determined by CT-derived Fractional Flow Reserve (FFR) calculations Receives: Diagnostic Test: CT-FFR |
| Angiography-derived FFR | Experimental | In this study arm, the need for coronary revascularization will be determined by FFR-calculations derived from angiographic images Receives: Diagnostic Test: Angiography-derived FFR |
| Routine Care | Active comparator | In this study arm, the need for coronary revascularization will be determined by angiography and invasive FFR-measurements Receives: Diagnostic Test: Angiography with invasive FFR-measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of non-invasive imaging techniques
The number of Major adverse cardiovasculare events (MACE) as all-cause mortality, aborted sudden cardiac death, myocardial infarction and unplanned hospitalization for chest pain leading to urgent revascularization in a 12 month follow-up period.
Measured: 12 months
Secondary outcomes (6)
Cost-effectiveness
Calculated using the total costs of the initial diagnostic tests, any additional tests or treatments for coronary artery disease, hospital admissions for suspected cardiac events and other costs that can be attributed to possible coronary artery disease. The medical costs will be calculated by the use of imta Medical Cost Questionnaire (iMCQ). Cost-effectiveness will be calculated by combining the total costs with the productivity loss using the iMTA Productivity Cost Questionnaire (iPCQ)
Measured: 12 months
Seattle Angina Pectoris Questionnaire
This questionnaire focuses on the presence of and limits caused by angina pectoris symptoms
Measured: 12 months
PHQ-9 Questionnaire
The Patient Health Questionnaire focuses on the mental health of the subject
Measured: 12 months
PROMIS-10 Questionnaire
This questionnaire focuses on the overall health care consumption of the subject
Measured: 12 months
Avoided coronary angiographies
To determine the fraction of avoided Cardiac Angiography's measurement by the use of CT-FFR. This is done by substracting the number of subjects in the CT-FFR group that received invasive angiography during the follow-up period from the total number of subjects in the CT-FFR group. Without the use of CT-FFR, all subjects in this group would have received invasive coronary angiography.
Measured: 12 months
Avoided invasive FFR-measurements
To determine the fraction of avoided FFR measurement by the use of angiography-derived FFR-calculations. This is done by substracting the number of subjects in het angiography-based FFR-group that received invasive FFR-measurements during the follow-up from the total number of subjects in the angiography-based FFR-group that would have received invasive FFR-measurements based on their angiographic views if angiography-based FFR would not have been available. Many of the subjects in this group would have received invasive FFR-measurements if angiography-based FFR would not have been available.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start22 Mar 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After coronary CT-scan, patients will be randomized in one of three possible study arms. One arm will receive additional CT-derived calculation of coronary blood flow, one arm will receive angiography-derived calculation of coronary blood flow and one arm will receive standard routine care. Standard care consists of coronary angiography and invasive coronary blood flow measurements. The results of these tests determine the need for treatment of coronary artery disease. After these tests, patients will be treated and followed according to routine care guidelines.
- Masking
- None (open label)
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, UMC Utrecht
- Responsible party
- Principal investigator, Martin J. Swaans, St. Antonius Hospital
- Investigators
- Martin J Swaans, Dr., Principal investigator, St. Antonius Ziekenhuis NieuwegeinTim Leiner, Prof. Dr., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939207
- Sponsor's protocol ID
- NL7739.100.21
- Other IDs
- 852002131
- Acronym
- iCORONARY
- Status last verified
- Nov 2024
- First submitted
- 7 Jun 2021
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: At the end of the study, the data will be locally saved at the st. Antonius Hospital and can be made available at request for reuse in other studies.
Publications
Peper J, Becker LM, Bruning TA, Budde RPJ, van Dockum WG, Frederix GWJ, Habets J, Henriques JPS, Houthuizen P, Mohamed Hoesein FAA, Planken RN, Voskuil M, Bots ML, Leiner T, Swaans MJ. Rationale and design of the iCORONARY trial: improving the cost-effectiveness of coronary artery disease diagnosis. Neth Heart J. 2023 Apr;31(4):150-156. doi: 10.1007/s12471-023-01758-3. Epub 2023 Jan 31.
PubMed 36720801
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Cost-effectiveness of Coronary Artery Disease Diagnosis
- ClinicalTrials.gov ID
- NCT04939207
- Acronym / sponsor ID
- iCORONARY / NL7739.100.21
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Angina pectoris, Coronary arteriosclerosis, CT scan, Cardiac catheterization, Coronary angiography, Myocardial fractional flow reserve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, UMC Utrecht
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 25 Jun 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.
Yearly, 180 000 patients in the Netherlands are referred to a cardiologist with symptoms suspected of coronary artery disease (CAD). To assess this, multiple diagnostic tests are available. Non-invasive imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out CAD. However, when CAD is present, coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis. Cardiac angiography with invasive blood flow measurements is required to assess this restriction in blood flow. This is an invasive test, more expensive than CT and it is accompanied by certain risks.
Most patients in whom CAD is present do not need treatment, and would therefore benefit from non-invasive diagnostic tests. To reduce the number of unnecessary cardiac angiography with flow measurements, new imaging techniques have been developed. These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment. This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan.
Subjects are eligible if their CT-scan indicates possibly significant CAD. To determine need for treatment of a subject's CAD, the investigators will randomize subjects in three arms. One arm consists of additional CT-derived calculation of coronary blood flow, one arm consists of angiography-derived calculation of coronary blood flow and one arm consists of standard care, coronary angiography and invasive coronary blood flow measurements. After these tests, subjects are treated and followed according to routine care guidelines. Additionally, subjects are requested to complete 5 questionnaires in a 12 month follow-up period.
The investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques. The investigators expect that this will lead to a reduction in healthcare costs, complications and a lower burden of diagnostic tests for patients. The investigators do not expect a difference in primary endpoints between the study groups.
Detailed description
Only a small proportion of the 180 000 patients that are referred to a cardiologist each year in the Netherlands with complaints of angina pectoris or shortness of breath suffer from coronary stenosis in such a degree that revascularisation is required. To identify these patients, multiple diagnostic tests are available. Simple non-interventional imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out coronary artery disease. However, when coronary artery disease is present, coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis. Cardiac angiography with invasive blood flow measurements is required to assess this restriction in blood flow. This is an invasive test, more expensive than CT and it is accompanied by certain risks.
In retrospect, many patients unnecessarily undergo cardiac angiography with, if deemed neccessary, flow measurements. These patients do not need treatment for coronary artery disease. To reduce the number of unnecessary cardiac angiography with flow measurements, new imaging techniques have been developed. These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment. These new imaging techniques have been tested extensively in observational studies. Currently, there is no consensus in the optimal diagnostic pathway resulting in major differences in strategies between hospitals. Moreover,data on cost-effectiveness is lacking.
This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan. Our target population will be patients with complaints of angina pectoris or shortness of breath for which the patients will undergo coronary CT-scan. If the CT-scan shows one or more possibly flow-limiting stenoses, further diagnostic testing is required. These subjects are randomized in one of three possible arms. One arm will receive additional CT-derived calculation of coronary blood flow, one arm will receive angiography-derived calculation of coronary blood flow and one arm will receive standard care. Standard care consists of coronary angiography and invasive coronary blood flow measurements. The results of these tests determine the need for treatment of coronary artery disease. After these tests, subjects are treated according to routine care guidelines. Subjects are requested to complete 5 questionnaires in a 12 month follow-up period. The primary endpoint is a composite of MACE - all-cause mortality, aborted sudden cardiac death, myocardial infarction and unplanned hospitalization for chest pain leading to urgent revascularization during the 12-month follow-up period. Secondary endpoints consist of cost-effectiveness, the number of avoided invasive coronary angiographies and flow measurements and quality of life. The investigators will use hospital patient files and completed questionnaires to collect information about events during the follow-up period until the last included subject has completed their final questionnaire.
The investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques. The investigators expect that this will lead to a reduction in healthcare costs, complications and a lower burden of diagnostic tests for patients. The investigators do not expect a difference in primary endpoints between the study groups.
In addition to the randomised controlled trial, all eligible subjects whose coronary CT-scan does not show possibly significant coronary artery disease (CAD-RADS 0-2) are included in a patient registry. Because of absent or limited coronary artery disease, additional diagnostic testing is not needed in these patients. These subjects are requested to answer 5 questionnaires in a 12-month period, similar to the subjects included in the RCT-part of the trial. The outcome measures of this part of the trial are similar to those of the RCT. Our primary outcome is the occurrence of MACE-events, secondary outcomes are quality of life and patient satisfaction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- After coronary CT-scan, patients will be randomized in one of three possible study arms. One arm will receive additional CT-derived calculation of coronary blood flow, one arm will receive angiography-derived calculation of coronary blood flow and one arm will receive standard routine care. Standard care consists of coronary angiography and invasive coronary blood flow measurements. The results of these tests determine the need for treatment of coronary artery disease. After these tests, patients will be treated and followed according to routine care guidelines.
| Arm | Type | Receives |
|---|---|---|
| CT-derived FFR | Experimental | Diagnostic Test: CT-FFRIn this study arm, the need for coronary revascularization will be determined by CT-derived Fractional Flow Reserve (FFR) calculations |
| Angiography-derived FFR | Experimental | Diagnostic Test: Angiography-derived FFRIn this study arm, the need for coronary revascularization will be determined by FFR-calculations derived from angiographic images |
| Routine Care | Active comparator | Diagnostic Test: Angiography with invasive FFR-measurementsIn this study arm, the need for coronary revascularization will be determined by angiography and invasive FFR-measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject is willing and able to provide informed consent and adhere to study rules and regulations and follow-up
- The subject is clinically suspected of having (recurrent) angina pectoris or an equivalent and suspected coronary artery disease, based on symptoms and signs, history, clinical examination and baseline diagnostic testing (e.g. ECG recording and laboratory tests) as described in the 2019 ESC guideline on chronic coronary syndromes.
- The subject has had ≥64 multidetector row coronary CTA or will undergo coronary CTA as part of usual care deemed by the treating physician with ≥64 multidetector row coronary CTA.
Key exclusion criteria (16 listed)
- The subject is suffering from unstable angina pectoris.
- The subject is suffering from decompensated congestive cardiac failure.
- The subject is suffering from a known non-ischemic cardiomyopathy.
- The subject has a history of PCI or CABG.
- The subject has had pacemaker or internal defibrillator leads implanted.
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 |
|---|---|---|
| CT-FFRCT-images will be processed by an algorithm to calculate FFR-values of the full coronary tree | Diagnostic test | CT-derived FFR |
| Angiography-derived FFRFFR-values are calculated during coronary angiography based on the acquired images of the coronary arteries | Diagnostic test | Angiography-derived FFR |
| Angiography with invasive FFR-measurementsduring coronary angiography, a specialized pressure wire is passed through the coronary stenosis to calculate FFR based on the difference between the actual pressure and the expected pressure in the hypothetical healthy coronary artery. | Diagnostic test | Routine Care |
Primary outcome
Safety of non-invasive imaging techniques
Time frame: 12 months
The number of Major adverse cardiovasculare events (MACE) as all-cause mortality, aborted sudden cardiac death, myocardial infarction and unplanned hospitalization for chest pain leading to urgent revascularization in a 12 month follow-up period.
6 secondary outcomes
Cost-effectiveness
Time frame: 12 months
Seattle Angina Pectoris Questionnaire
Time frame: 12 months
PHQ-9 Questionnaire
Time frame: 12 months
PROMIS-10 Questionnaire
Time frame: 12 months
Avoided coronary angiographies
Time frame: 12 months
Avoided invasive FFR-measurements
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Derived from this study: PubMed 36720801Peper J, Becker LM, Bruning TA, Budde RPJ, van Dockum WG, Frederix GWJ, Habets J, Henriques JPS, Houthuizen P, Mohamed Hoesein FAA, Planken RN, Voskuil M, Bots ML, Leiner T, Swaans MJ. Rationale and design of the iCORONARY trial: improving the cost-effectiveness of coronary artery disease diagnosis. Neth Heart J. 2023 Apr;31(4):150-156. doi: 10.1007/s12471-023-01758-3. Epub 2023 Jan 31.
- Individual participant dataSharing planned: Yes. At the end of the study, the data will be locally saved at the st. Antonius Hospital and can be made available at request for reuse in other studies.
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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.
Martin J Swaans, Dr. principal investigator
St. Antonius Ziekenhuis Nieuwegein
Tim Leiner, Prof. Dr. principal investigator
UMC Utrecht
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-FFR, Angiography-derived FFR and Angiography with invasive FFR-measurements in people with Coronary Artery Disease, run by St. Antonius Hospital at 4 sites in Netherlands.
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 3 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin J Swaans, Dr. (+31 (0)88 320 0900, m.swaans@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of non-invasive imaging techniques (time frame: 12 months). 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 NCT04939207, which also lists 1 linked publication.
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 2 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.