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Cost-effectiveness and Safety of the CADScorSystem in Patients With Symptoms Suggestive of Stable Coronary Artery Disease. (FILTER-SCAD)

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ClinicalTrials.gov Identifier: NCT04121949
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : November 11, 2019
Sponsor:
Collaborators:
Region Hovedstaden
Larix A/S
Acarix
Kai Hansens Fond
Kai Houmann Nielsens Fond
Information provided by (Responsible Party):
Eva Prescott, University Hospital Bispebjerg and Frederiksberg

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Angina, Stable Device: CADScor®System Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: Allocation will be hidden from the independent Clinical Events Committee.
Primary Purpose: Diagnostic
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.
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
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%.
Experimental: Intervention group
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.
Device: CADScor®System
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of Major adverse cardiac events (MACE) [ Time Frame: 1 year ]
    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.


Other Outcome Measures:
  1. Change in chest pain [ Time Frame: 3 months and 1 year ]
    Change in chest pain from baseline as assessed by the Seattle Angina Questionnaire (SAQ).

  2. Change in quality of life [ Time Frame: 3 months and 1 year ]
    Change in quality of life from baseline as assessed by the EuroQoL-5D.

  3. First non-invasive tests [ Time Frame: 1 year ]
    Difference between the two treatment groups in the number of first non-invasive testings.

  4. Downstream tests [ Time Frame: 1 year ]
    Difference between the two treatment groups in the number of downstream tests. Downstream tests are defined as all NITs and ICAs to detect CAD performed after a) DF-score and first standard non-invasive testing and b) DF-score, CAD-score and first non-invasive testing, respectively, in the two groups.

  5. Invasive coronary angiographies (ICA) [ Time Frame: 1 year ]
    Difference between the two treatment groups in the number of invasive coronary angiographies.

  6. Negative invasive coronary angiographies [ Time Frame: 1 year ]
    Difference between the two treatment groups in the number of negative invasive coronary angiographies.

  7. Repeat referrals [ Time Frame: 1 year ]
    Difference between the two treatment groups in the number of repeat referrals.

  8. Time to rule-out CAD [ Time Frame: 1 year ]
    Difference between the two treatment groups in time to rule-out CAD. Time to rule-out is assessed as the period from randomisation until the first test that rules out stable CAD.

  9. Time to diagnosis of CAD [ Time Frame: 1 year ]
    Difference between the two treatment groups in time to diagnosis of CAD. Time to diagnosis is assessed as the period from randomisation until the first test that leads to the final diagnosis.

  10. Change in lifestyle measures [ Time Frame: 3 months and 1 year ]
    Change in lifestyle measures from baseline as assessed by the HeartDiet questionnaire.

  11. Optimal medical treatment [ Time Frame: 1 year ]
    Difference between the two treatment groups in the proportion of patients initiating and adhering to optimal medical treatment (event prevention, antianginal therapy).

  12. Incidence of individual components of MACE [ Time Frame: 1 year ]
    Difference between the two treatment groups in the proportion of each of the individual components of major adverse cardiac events (all-cause death, myocardial infarction, unstable angina pectoris, heart failure, ischaemic stroke).

  13. Cumulative contrast dose [ Time Frame: 1 year ]
    Difference between the two treatment groups in the cumulative contrast dose.

  14. Cumulative radiation dose [ Time Frame: 1 year ]
    Difference between the two treatment groups in the cumulative radiation dose.

  15. Bleedings requiring hospitalization [ Time Frame: 1 year ]
    Difference between the two treatment groups in the proportion of bleedings requiring hospitalization.

  16. Adverse events [ Time Frame: 1 year ]
    Difference between the two treatment groups in the proportion adverse events related to the CADScor®System.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have signed the informed consent form.
  2. Males and females, aged 30 years or above.
  3. Be able and willing to comply with the clinical investigational plan.
  4. Symptoms suggestive of stable coronary artery disease.
  5. No history of coronary artery disease (prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).

Exclusion Criteria:

  1. Diamond-Forrester score >85%.
  2. Prior non-invasive testing for stable CAD or invasive coronary angiography within 6 months of randomization.
  3. Implanted donor heart, mechanical heart, mechanical heart pump.
  4. Pacemaker or Cardioverter Defibrillator (ICD).
  5. Implanted electronic equipment in the area above and around the heart.
  6. Significant operation scars, abnormal body shape, fragile or compromised skin in the fourth left intercostal space recording area.
  7. Receiving same day treatment with nitro-glycerine on the day of randomization.
  8. Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121949


Contacts
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Contact: Kim W Hansen, MD, PhD 40262059 ext +45 kim.wadt.hansen@regionh.dk
Contact: Louise H Bjerking, MD 30507406 ext +45 louise.hougesen.bjerking@regionh.dk

Locations
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Denmark
University Hospital Herlev and Gentofte Not yet recruiting
Herlev, Denmark, 2730
Contact: Kristian Eskesen, MD PhD         
University Hospital Nordsjaelland Not yet recruiting
Hillerød, Denmark, 3400
Contact: Sune Räder, MD PhD         
University Hospital Amager and Hvidovre Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Jens Hove, MD PhD MSc         
University Hospital Bispebjerg and Frederiksberg Recruiting
København NV, Denmark, 2400
Contact: Merete Heitmann, MD, PhD         
Sweden
Skane University Hospital Not yet recruiting
Lund, Sweden, 222 42
Contact: David Erlinge, MD PhD FESC         
Contact: Henrik Engblom, MD PhD         
Sponsors and Collaborators
Bispebjerg Hospital
Region Hovedstaden
Larix A/S
Acarix
Kai Hansens Fond
Kai Houmann Nielsens Fond
Investigators
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Principal Investigator: Eva Prescott, DMSc. Bispebjerg og Frederiksberg Hospitaler
Principal Investigator: Søren Galatius, DMSc. Bispebjerg og Frederiksberg Hospitaler

Publications:
Task Force Members, Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabaté M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines, Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers, Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Rydén L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. Erratum in: Eur Heart J. 2014 Sep 1;35(33):2260-1.

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Responsible Party: Eva Prescott, Professor, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT04121949     History of Changes
Other Study ID Numbers: FILTER-SCAD
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eva Prescott, University Hospital Bispebjerg and Frederiksberg:
coronary artery disease
diagnostic strategies
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms