Multisensor Array for the Localisation of Coronary Artery Stenosis (MALCAS)

NCT04647448 | Withdrawn DMC

• 1 other identifier: 274197
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a proof of concept study involving a novel medical device, developed to investigate the potential for detecting and localising coronary artery stenosis. A prototype device will be used in the proposed clinical investigation. It is a stick-on patch containing sensors which measure the sound produced at and the movement of, the chest surface by flowing blood as it accelerates through the stenosis and becomes disturbed as it emerges downstream, allowing the blockage to be detected and localised non-invasively. The proposed clinical investigation will involve a small number of patients and healthy volunteers. The patients will be drawn from those attending The BartsHeart Centre for suspected or diagnosed coronary artery disease and all clinical measurements will take place at Barts Health Trust. The patch to be used in the proposed clinical investigation incorporates commercially available sensors and will be tested by recording acoustic signatures in healthy volunteers, then in patients undergoing coronary CT angiography at Barts. Signals will be analysed initially by measuring their acoustic energy at various frequencies and in later iterations, by a machine-learning algorithm. Results will be validated against the CT angiography gold standard.

Conditions

CORONARY ARTERY DISEASE

Keywords

Phono-cardiography

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Diagnostic accuracy of the device (stick-on patch) for indicating the presence or absence of one or more coronary arterial stenoses as indicated by the reference method (CT angiography results)

  Through study completion, 1 year

Secondary Outcomes (3)

• Stenosis severity

  Through study completion, 1 year

• Number of stenoses

  Through study completion, 1 year

• Stenosis position

  Through study completion, 1 year

Study Arms (2)

Healthy volunteers

Participants with no known cardiovascular disease

Diagnostic Test: Application of sensor patch

Chest pain

Patients with symptoms of chest pain, undergoing elective coronary artery CT

Diagnostic Test: Application of sensor patch

Interventions

Application of sensor patch DIAGNOSTIC_TEST

Application of sensor patch to chest to record acoustic signals due to disturbed blood flow.

Chest pain; Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female, minimum age 18 years. Healthy volunteers selected by advertisement Patients selected from those attending Barts Heart Centre for elective coronary CT angiography.

You may qualify if:

• Healthy
• Not pregnant
• Presenting with chest pain with possibility of coronary artery disease
• No infectious disease or neoplasia

You may not qualify if:

• Considered by the study clinician to be unsuitable to participate
• Considered by the clinical research team to be incapable of providing written informed consent for any reason.
• Considered by the clinical research team to be incapable of providing written informed consent for any reason.
• Considered by their healthcare professional to be unsuitable to participate
• Participation in another ongoing drug or medical device study
• Participation in a drug study within the 3 months prior to the date of potential enrolment into this study

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Imperial College London: collaborator
• Brunel University: collaborator

Related Publications (5)

• Andrus BW, Welch HG. Medicare services provided by cardiologists in the United States: 1999-2008. Circ Cardiovasc Qual Outcomes. 2012 Jan;5(1):31-6. doi: 10.1161/CIRCOUTCOMES.111.961813. Epub 2012 Jan 10.

  PMID: 22235064 BACKGROUND

• Ladapo JA, Blecker S, Douglas PS. Physician decision making and trends in the use of cardiac stress testing in the United States: an analysis of repeated cross-sectional data. Ann Intern Med. 2014 Oct 7;161(7):482-90. doi: 10.7326/M14-0296.

  PMID: 25285541 BACKGROUND

• Nichols M, Townsend N, Scarborough P, Rayner M. Cardiovascular disease in Europe 2014: epidemiological update. Eur Heart J. 2014 Nov 7;35(42):2950-9. doi: 10.1093/eurheartj/ehu299. Epub 2014 Aug 19.

  PMID: 25139896 BACKGROUND

• Patel MR, Peterson ED, Dai D, Brennan JM, Redberg RF, Anderson HV, Brindis RG, Douglas PS. Low diagnostic yield of elective coronary angiography. N Engl J Med. 2010 Mar 11;362(10):886-95. doi: 10.1056/NEJMoa0907272.

  PMID: 20220183 BACKGROUND

• Villadsen PR, Petersen SE, Dey D, Zou L, Patel S, Naderi H, Gruszczynska K, Baron J, Davies LC, Wragg A, Botker HE, Pugliese F. Coronary atherosclerotic plaque burden and composition by CT angiography in Caucasian and South Asian patients with stable chest pain. Eur Heart J Cardiovasc Imaging. 2017 May 1;18(5):556-567. doi: 10.1093/ehjci/jew085.

  PMID: 27225816 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: December 1, 2020
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share