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

NCT04121949 | Completed DMC

• 1 other identifier: FILTER-SCAD
• Study Type: interventional
• Target: 2,016
• Locations: 2 countries
• Sites: 6

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.

Conditions

Angina, Stable

Keywords

coronary artery disease; diagnostic strategies

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Incidence of Major adverse cardiac events (MACE)

  1 year

Other Outcomes (16)

• Change in chest pain

  3 months and 1 year

• Change in quality of life

  3 months and 1 year

• First non-invasive tests

  1 year

Study Arms (2)

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.

Device: CADScor®System

Interventions

CADScor®System DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Receiving same day treatment with nitro-glycerine on the day of randomization.
• Pregnancy.

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Region Hovedstadens Apotek: collaborator
• Larix A/S: collaborator
• Acarix: collaborator
• Kai Hansen Foundation: collaborator
• Kai Houmann Nielsens Fond: collaborator

Study Sites (6)

Amager Hospital

Copenhagen S, 2300, Denmark

Location

University Hospital Herlev and Gentofte

Herlev, 2730, Denmark

Location

University Hospital Nordsjaelland

Hillerød, 3400, Denmark

Location

University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

University Hospital Bispebjerg and Frederiksberg

København NV, 2400, Denmark

Location

Skane University Hospital

Lund, 222 42, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34426466 DERIVED

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Eva Prescott, DMSc.

  Bispebjerg og Frederiksberg Hospitaler

  PRINCIPAL INVESTIGATOR

• Søren Galatius, DMSc.

  Bispebjerg og Frederiksberg Hospitaler

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Allocation will be hidden from the independent Clinical Events Committee.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: July 1, 2019
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

DK (5); SE (1)