Angina, StableFILTER-SCADNCT04121949
Cost-effectiveness and Safety of the CADScorSystem in Patients With Symptoms Suggestive of Stable Coronary Artery Disease.
A study testing CADScor®System in people with Angina, Stable, run by Bispebjerg Hospital at 6 sites in 2 countries.
Trial summary
This study evaluates the addition of the CADScorSystem to a standard Diamond-Forrester score guided rule-out strategy in ambulatory patients referred with symptoms suggestive of stable coronary artery disease. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Angina, Stable
- What is being tested?
- CADScor®System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,016 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Jul 2019to 15 Sep 2023
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed the informed consent form.
- Males and females, aged 30 years or above.
- Be able and willing to comply with the clinical investigational plan.
- Symptoms suggestive of stable coronary artery disease.
- No history of coronary artery disease (prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).
Who cannot join
- Diamond-Forrester score >85%.
- Prior non-invasive testing for stable CAD or invasive coronary angiography within 6 months of randomization.
- Implanted donor heart, mechanical heart, mechanical heart pump.
- Pacemaker or Cardioverter Defibrillator (ICD).
- Implanted electronic equipment in the area above and around the heart.
- Significant operation scars, abnormal body shape, fragile or compromised skin in the fourth left intercostal space recording area.
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- Receiving same day treatment with nitro-glycerine on the day of randomization.
- Pregnancy.
- The exclusion criteria '1. Diamond-Forrester score >85%' was removed after updating the study according to the 2019 ESC guidelines on chronic coronary syndrome. According to these current guidelines, no patients should be referred to invasive diagnostic test based on their PTP alone, and therefore is this exclusion criteria is no longer relevant.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Denmark5 sites
Amager Hospital
Copenhagen S, 2300
University Hospital Herlev and Gentofte
Herlev, 2730
University Hospital Nordsjaelland
Hillerød, 3400
University Hospital Hvidovre
Hvidovre, 2650
University Hospital Bispebjerg and Frederiksberg
København NV, 2400
About this study
Official title: A Prospective, Randomized, Controlled, Parallel-group, Multicentre Trial to Examine the Cost-effectiveness and Safety of Adding the CADScorSystem as a Rule-out Test in Patients Referred With Symptoms Suggestive of Stable Coronary Artery Disease.
This study evaluates the addition of the CADScorSystem to a standard Diamond-Forrester score guided rule-out strategy in ambulatory patients referred with symptoms suggestive of stable coronary artery disease. Half of the patients will undergo stratification using a Diamond-Forrester score only, while the other half will undergo stratification using a Diamond-Forrester score and a CAD-score. The study hypothesis is that the addition of a CAD-score will reduce unnecessary testing without compromising patient safety.
Read the detailed description
Purpose and Rationale for the Study:
The declining incidence of obstructive CAD and a good prognosis for patients with stable angina challenges the resource demanding approach recommended in current guidelines. The CADScor®System may be an efficient, fast and low-cost diagnostic tool with a high rule-out efficiency. The current study aims to investigate if the CADScor®System can be added as a rule-out test in patients referred with suspected stable CAD to reduce unnecessary testing
Study Hypothesis:
A Diamond-Forrester score plus CAD-score guided rule-out strategy is superior to a Diamond-Forrester score guided strategy alone in reducing diagnostic procedures and non-inferior in terms of safety outcomes in patients with symptoms suggestive of stable coronary artery disease.
Study Setting:
This study will enrol patients without known CAD who are referred with symptoms suggestive for stable CAD for outpatient evaluation at the participating sites. All patients will be symptomatic and require evaluation for suspected CAD. Thus, whether or not the patient chooses to participate in the study, the patient will undergo evaluation for suspected CAD. All the standard NIT modalities and ICA in the study are clinically well established and performed routinely and safely. Experimental testing involves the CADScor®System, for ruling out CAD before any NIT in the intervention group.
End of Study:
The study will end when all the following have occurred: (1) at least 2000 patients have been randomized, and (2) 12±1 months (1 year) have elapsed since the last patient was randomized.
Extended Follow-up after Study Termination:
Follow-up might be performed for up to 10 years after randomization. Follow-up information will be extracted from national registers, including information on cardiovascular events and treatments, hospitalizations and ambulatory visits due to cardiovascular events, and causes of death.
Statistical methods:
A detailed description of the planned statistical analyses will be documented in a separate statistical report and analysis plan (SAP), which will be completed before data base lock.
Sample size considerations:
A reduction of 15% or more in the primary endpoint is regarded as clinically significant. Assuming an alpha significance level of 0.05, a statistical power of 80% and an expected number of NIT/ICA of 0.94 per patient in the standard care group, a sample size of 314 patients in each arm is needed to ascertain superiority of the intervention.
A sample size of 1914 provides 90% power for testing non-inferiority in terms of MACE between the two testing strategies, at an alpha significance level of 0.05.
We choose to include 2000 patients, i.e. 1000 patients in each group, allowing for a 4% loss to follow-up and drop out and providing power for the primary endpoint and the secondary MACE non-inferiority endpoint.
Statistical analysis:
The full analysis set (FAS) will include all randomized patients in whom written informed consent was obtained and in accordance with the intention-to-treat principle all patients will be analysed according to the allocated treatment group.
The per-protocol set (PPS) will include only those patients from the FAS who did not have one of the following major protocol violations: inclusion criteria not met, exclusion criteria met, no DF-score calculation, or no CAD-score measurement (intervention group only). Patients who did not receive the randomly allocated CAD-score measurement will be included and analysed in the control group (per protocol analysis).
- Conditions
- Angina, Stable
- Being tested
- CADScor®System
- Keywords
- coronary artery disease, diagnostic strategies
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADScor®SystemDevice
The CADScor®System is a low cost, low resource-demanding, non-invasive, radiation-free device using highly advanced analysis of sounds originating from blood flow turbulence in the coronary circulation and myocardial motion. Heart sound recordings are obtained transcutaneously during a 3 minutes recording period with a microphone mounted at the IC4. A CAD-score on a scale from 0 to 99 is estimated immediately after the recording with a fully automated algorithm. The algorithm measures eight acoustic properties and the resulting acoustic score is combined with the clinical risk factors gender, age, and hypertension. The entire procedure lasts approximately 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will receive standard-of-care treatment recommended by current ESC guidelines for patients with low to intermediate likelihood of stable CAD using the Diamond-Forrester (DF) score only: Rule-out if DF-score <15%; NIT if DF-score 15-85%. As per January 2020 the protocol was updated according to the 2019 ESC Guidelines on Chronic Coronary Syndrome: The control group will receive standard-of-care treatment recommended by current ESC guidelines based on the patients likelihood of stable CAD using the Pre-test Probability score (PTP): Rule-out if PTP≤5%, NIT may be considered if PTP 6-15%, NIT if PTP>15% |
| Intervention group | Experimental | The intervention group will undergo a modified diagnostic pathway where a CAD-score <30 rules out stable CAD in the group of patients having a DF-score <15% and a CAD-score ≤20 rules out stable CAD in the group of patients having a DF-score in the range 15-85%, and thus not tested with NIT. Otherwise NIT is performed.
As per January 2020 the protocol was updated according to the 2019 ESC Guidelines on Chronic Coronary Syndrome:
The intervention group will undergo a modified diagnostic pathway where a CAD-score ≤20 rules out stable CAD. If CAD-score >20 NIT is performed. Receives: Device: CADScor®System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative number of non-invasive and invasive diagnostic procedures
Difference between the two treatment groups in cumulative number of non-invasive and invasive diagnostic procedures. Non-invasive procedures include exercise electrocardiogram (ECG), cardiac computed tomography angiography (CCTA), Rubidium cardiac PET (Rb-PET), myocardial perfusion imaging (MPI), cardiac magnetic resonance imaging (CMRi) and stress echocardiography. Invasive procedures include invasive coronary angiography (ICA) only.
Measured: 1 year
Secondary outcomes (1)
Incidence of Major adverse cardiac events (MACE)
Difference between the two treatment groups in proportion of major adverse cardiac events. Major adverse cardiac events (MACE) are a composite of all-cause death, non-fatal myocardial infarction, unstable angina pectoris, heart failure, and ischaemic stroke.
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 Oct 2019
- Study start1 Jul 2019
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
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 Angina, StableStudies 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
- This study is designed as a randomized, controlled, multicentre, superiority trial with two parallel groups including patients with symptoms suggestive of stable CAD at a low-to-intermediate likelihood of obstructive CAD (pre-test probability of 0-85%). Subjects will be randomized 1:1 to either (1) standard diagnostic strategy according to current guidelines, i.e. DF-score stratification followed by NIT, if indicated, or (2) DF-score plus CAD-score stratification followed by NIT, if indicated.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Hovedstadens Apotek, Larix A/S, Acarix, Kai Hansen Foundation, Kai Houmann Nielsens Fond
- Responsible party
- Principal investigator, Eva Prescott, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Eva Prescott, DMSc., Principal investigator, Bispebjerg og Frederiksberg HospitalerSøren Galatius, DMSc., Principal investigator, Bispebjerg og Frederiksberg Hospitaler
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121949
- Sponsor's protocol ID
- FILTER-SCAD
- Acronym
- FILTER-SCAD
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2019
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bjerking LH, Hansen KW, Biering-Sorensen T, Bronnum-Schou J, Engblom H, Erlinge D, Haahr-Pedersen SA, Heitmann M, Hove JD, Jensen MT, Kruse M, Rader S, Strange S, Galatius S, Prescott EIB. Cost-effectiveness of adding a non-invasive acoustic rule-out test in the evaluation of patients with symptoms suggestive of coronary artery disease: rationale and design of the prospective, randomised, controlled, parallel-group multicenter FILTER-SCAD trial. BMJ Open. 2021 Aug 23;11(8):e049380. doi: 10.1136/bmjopen-2021-049380.
PubMed 34426466
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Parallel-group, Multicentre Trial to Examine the Cost-effectiveness and Safety of Adding the CADScorSystem as a Rule-out Test in Patients Referred With Symptoms Suggestive of Stable Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT04121949
- Acronym / sponsor ID
- FILTER-SCAD / FILTER-SCAD
- Conditions
- Angina, Stable
- Keywords
- coronary artery disease, diagnostic strategies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,016 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Region Hovedstadens Apotek, Larix A/S, Acarix, Kai Hansen Foundation, Kai Houmann Nielsens Fond
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 10 Oct 2019 (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.
This study evaluates the addition of the CADScorSystem to a standard Diamond-Forrester score guided rule-out strategy in ambulatory patients referred with symptoms suggestive of stable coronary artery disease. Half of the patients will undergo stratification using a Diamond-Forrester score only, while the other half will undergo stratification using a Diamond-Forrester score and a CAD-score. The study hypothesis is that the addition of a CAD-score will reduce unnecessary testing without compromising patient safety.
Detailed description
Purpose and Rationale for the Study:
The declining incidence of obstructive CAD and a good prognosis for patients with stable angina challenges the resource demanding approach recommended in current guidelines. The CADScor®System may be an efficient, fast and low-cost diagnostic tool with a high rule-out efficiency. The current study aims to investigate if the CADScor®System can be added as a rule-out test in patients referred with suspected stable CAD to reduce unnecessary testing
Study Hypothesis:
A Diamond-Forrester score plus CAD-score guided rule-out strategy is superior to a Diamond-Forrester score guided strategy alone in reducing diagnostic procedures and non-inferior in terms of safety outcomes in patients with symptoms suggestive of stable coronary artery disease.
Study Setting:
This study will enrol patients without known CAD who are referred with symptoms suggestive for stable CAD for outpatient evaluation at the participating sites. All patients will be symptomatic and require evaluation for suspected CAD. Thus, whether or not the patient chooses to participate in the study, the patient will undergo evaluation for suspected CAD. All the standard NIT modalities and ICA in the study are clinically well established and performed routinely and safely. Experimental testing involves the CADScor®System, for ruling out CAD before any NIT in the intervention group.
End of Study:
The study will end when all the following have occurred: (1) at least 2000 patients have been randomized, and (2) 12±1 months (1 year) have elapsed since the last patient was randomized.
Extended Follow-up after Study Termination:
Follow-up might be performed for up to 10 years after randomization. Follow-up information will be extracted from national registers, including information on cardiovascular events and treatments, hospitalizations and ambulatory visits due to cardiovascular events, and causes of death.
Statistical methods:
A detailed description of the planned statistical analyses will be documented in a separate statistical report and analysis plan (SAP), which will be completed before data base lock.
Sample size considerations:
A reduction of 15% or more in the primary endpoint is regarded as clinically significant. Assuming an alpha significance level of 0.05, a statistical power of 80% and an expected number of NIT/ICA of 0.94 per patient in the standard care group, a sample size of 314 patients in each arm is needed to ascertain superiority of the intervention.
A sample size of 1914 provides 90% power for testing non-inferiority in terms of MACE between the two testing strategies, at an alpha significance level of 0.05.
We choose to include 2000 patients, i.e. 1000 patients in each group, allowing for a 4% loss to follow-up and drop out and providing power for the primary endpoint and the secondary MACE non-inferiority endpoint.
Statistical analysis:
The full analysis set (FAS) will include all randomized patients in whom written informed consent was obtained and in accordance with the intention-to-treat principle all patients will be analysed according to the allocated treatment group.
The per-protocol set (PPS) will include only those patients from the FAS who did not have one of the following major protocol violations: inclusion criteria not met, exclusion criteria met, no DF-score calculation, or no CAD-score measurement (intervention group only). Patients who did not receive the randomly allocated CAD-score measurement will be included and analysed in the control group (per protocol analysis).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomized, controlled, multicentre, superiority trial with two parallel groups including patients with symptoms suggestive of stable CAD at a low-to-intermediate likelihood of obstructive CAD (pre-test probability of 0-85%). Subjects will be randomized 1:1 to either (1) standard diagnostic strategy according to current guidelines, i.e. DF-score stratification followed by NIT, if indicated, or (2) DF-score plus CAD-score stratification followed by NIT, if indicated.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will receive standard-of-care treatment recommended by current ESC guidelines for patients with low to intermediate likelihood of stable CAD using the Diamond-Forrester (DF) score only: Rule-out if DF-score <15%; NIT if DF-score 15-85%. As per January 2020 the protocol was updated according to the 2019 ESC Guidelines on Chronic Coronary Syndrome: The control group will receive standard-of-care treatment recommended by current ESC guidelines based on the patients likelihood of stable CAD using the Pre-test Probability score (PTP): Rule-out if PTP≤5%, NIT may be considered if PTP 6-15%, NIT if PTP>15% |
| Intervention group | Experimental | Device: CADScor®SystemThe intervention group will undergo a modified diagnostic pathway where a CAD-score <30 rules out stable CAD in the group of patients having a DF-score <15% and a CAD-score ≤20 rules out stable CAD in the group of patients having a DF-score in the range 15-85%, and thus not tested with NIT. Otherwise NIT is performed. As per January 2020 the protocol was updated according to the 2019 ESC Guidelines on Chronic Coronary Syndrome: The intervention group will undergo a modified diagnostic pathway where a CAD-score ≤20 rules out stable CAD. If CAD-score >20 NIT is performed. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have signed the informed consent form.
- Males and females, aged 30 years or above.
- Be able and willing to comply with the clinical investigational plan.
- Symptoms suggestive of stable coronary artery disease.
- No history of coronary artery disease (prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).
Key exclusion criteria (9 listed)
- Diamond-Forrester score >85%.
- Prior non-invasive testing for stable CAD or invasive coronary angiography within 6 months of randomization.
- Implanted donor heart, mechanical heart, mechanical heart pump.
- Pacemaker or Cardioverter Defibrillator (ICD).
- Implanted electronic equipment in the area above and around the heart.
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 |
|---|---|---|
| CADScor®SystemThe CADScor®System is a low cost, low resource-demanding, non-invasive, radiation-free device using highly advanced analysis of sounds originating from blood flow turbulence in the coronary circulation and myocardial motion. Heart sound recordings are obtained transcutaneously during a 3 minutes recording period with a microphone mounted at the IC4. A CAD-score on a scale from 0 to 99 is estimated immediately after the recording with a fully automated algorithm. The algorithm measures eight acoustic properties and the resulting acoustic score is combined with the clinical risk factors gender, age, and hypertension. The entire procedure lasts approximately 10 minutes. | Device | Intervention group |
Primary outcome
Cumulative number of non-invasive and invasive diagnostic procedures
Time frame: 1 year
Difference between the two treatment groups in cumulative number of non-invasive and invasive diagnostic procedures. Non-invasive procedures include exercise electrocardiogram (ECG), cardiac computed tomography angiography (CCTA), Rubidium cardiac PET (Rb-PET), myocardial perfusion imaging (MPI), cardiac magnetic resonance imaging (CMRi) and stress echocardiography. Invasive procedures include invasive coronary angiography (ICA) only.
1 secondary outcome
Incidence of Major adverse cardiac events (MACE)
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 5 Oct 2023.
- Derived from this study: PubMed 34426466Bjerking LH, Hansen KW, Biering-Sorensen T, Bronnum-Schou J, Engblom H, Erlinge D, Haahr-Pedersen SA, Heitmann M, Hove JD, Jensen MT, Kruse M, Rader S, Strange S, Galatius S, Prescott EIB. Cost-effectiveness of adding a non-invasive acoustic rule-out test in the evaluation of patients with symptoms suggestive of coronary artery disease: rationale and design of the prospective, randomised, controlled, parallel-group multicenter FILTER-SCAD trial. BMJ Open. 2021 Aug 23;11(8):e049380. doi: 10.1136/bmjopen-2021-049380.
- 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.
Eva Prescott, DMSc. principal investigator
Bispebjerg og Frederiksberg Hospitaler
Søren Galatius, DMSc. principal investigator
Bispebjerg og Frederiksberg Hospitaler
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CADScor®System in people with Angina, Stable, run by Bispebjerg Hospital at 6 sites in 2 countries.
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 5 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 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, Sweden. 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?
Cumulative number of non-invasive and invasive diagnostic procedures (time frame: 1 year). 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 NCT04121949, 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 5 Oct 2023.