Evaluation of Diagnostic Accuracy, Safety, and Cost-Effectiveness of the Non-Invasive Cardiolens FFR-CT Pro Method to Measure the Fractional Flow Reserve in Diagnostics of Chronic Coronary Syndromes Versus the Standard Diagnostic Modalities.

May 14, 2024 updated by: Hemolens Diagnostics Sp. z o.o.

Evaluation of Diagnostic Accuracy, Safety, and Cost-Effectiveness of the Non-Invasive Cardiolens FFR-CT Pro Method to Measure the Fractional Flow Reserve in Diagnostics of Chronic Coronary Syndromes Versus the Standard Diagnostic Modalities. A Multicentre Post-marketing Trial of a Class 2a Medical Device, Cardiolens FFR-CT Pro - Software for Non-invasive Determination of Haemodynamic Parameters in Coronary Arteries.

A multicentre, post-marketing, observational trial in 450 patients, whose standard diagnostic workup for chronic coronary syndromes provided for Invasive Coronary Angiography (ICA). Medical records of a potential subject of the trial before their enrolment contain a good quality result of at least 128-slice CCTA performed up to 3 months before the elective ICA. CCTA should find at least one ≥50% stenosis in at least one big coronary artery of ≥ 2 mm diameter. At one hour before ICA in the latest the patient should have a resting Continuous Non-Invasive Blood Pressure (CNBP) taken with a certified device delivered by LifeFlow. The last criterion before including a patient in the final analysis is at least one significant (≥50%) stenosis in one or two coronary arteries of ≥ 2 mm diameter visually confirmed by ICA with a FFR measurement taken in these arteries.

The data collection period will cover time from admission for the elective ICA to discharge from the hospital (evaluation of possible adverse events related to invasive procedures).

After initial qualification of available data by the attending physician, selected patients will be asked for a consent to participation in the trial no later than upon admission for the elective ICA and before CNBP measurement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stage 1

After a patient declares their consent, a doctor or another member of the study team trained by the sponsor will perform procedures in the following order:

  • Define the unique patient ID to be recorded in the CRF with the patient's demographic data
  • Assess the quality of CCTA imaging data (DICOM) according to guidelines agreed upon with the sponsor and record the number and location of the significant (≥50%) stenosis sites in the CRF based on CCTA
  • No later than one hour before ICA starts, perform a physical examination consisting in instantaneous peripheral blood pressure (systolic and diastolic) resting measurement performed with a standard sphygmomanometer and Continuous Non-Invasive Blood Pressure measurement (1-3 min).

Stage 2

After the procedures mentioned above are performed, the patient will undergo elective ICA with the outcomes, i.e.:

  • video material showing the location of the wire during the FFR measurement,
  • digital pressure signals exported from the FFR measuring device used to determine the value of the invasive FFR,
  • values of FFR measurements obtained during ICA will be entered after being anonymised in a dedicated HEMOFLOW PMS_2020 reference database.

Stage 3

Within 48 hours of ICA completion a doctor or another member of the study team trained by the sponsor:

  • will enter the following data in the Cardiolens FFR-CT Pro system:

    1. Patient's data, i.e. patient's ID, gender, height, body mass, exercise tolerability, information on used medications and smoking cigarettes. Optionally, i.e. if upon admission for ICA a blood test was performed as a part of the standard diagnostic workup - haematocrit levels and total protein concentration
    2. Files containing CCTA imaging data in the DICOM format.
    3. Values of instantaneous peripheral blood pressure (systolic and diastolic) resting measurement performed with a standard sphygmomanometer as well as the digital signal obtained during the CNBP measurement (1-3 min)

  • Based on the CCTA description or meta data contained in the imaging data the doctor or another member of the study team will record the following information in the CRF:

    1. Radiation dose during CCTA
    2. Contrast medium dose during CCTA

  • Will enter the following information in the CRF:

    1. Radiation dose during the diagnostic part of ICA
    2. Contrast medium dose during the diagnostic part of ICA
    3. Number and type of adverse events
    4. Duration of the diagnostic workup.

Stage 4

Within 7 days of entering all the stage 3 data the investigator (a cardiologist) trained by the sponsor will measure the value of the virtual FFR with the Cardiolens FFR-CT Pro system at locations corresponding to ICA FFR measurements (based on video recording entered in the database during stage 2)

Based on results obtained from the Cardiolens FFR-CT Pro system vs reference data an analysis will be performed on meeting the primary and secondary end points of the trial.

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bielsko-Biala, Poland, 43-316
        • American Heart of Poland, Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej
      • Cracovia, Poland, 30-688
        • Oddział Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych Szpital Uniwersytecki w Krakowie
      • Cracovia, Poland, 31-202
        • The John Paul II Specialist Hospital in Cracovia
      • Gdańsk, Poland
        • The University Clinical Centre
      • Katowice, Poland
        • The Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University
      • Lubin, Poland, 59-301
        • "Miedziowe Centrum Zdrowia" S.A.
      • Ustroń, Poland, 43-450
        • American Heart of Poland, Centrum Sercowo - Naczyniowe w Ustroniu
      • Warsaw, Poland
        • The Cardinal Stefan Wyszyński National Institute of Cardiology
      • Wrocław, Poland
        • The 4th Military Teaching Hospital
      • Wrocław, Poland
        • The Jan Mikulicz-Radecki University Teaching Hospital
      • Wrocław, Poland
        • The T. Marciniak Lower Silesian Specialist Hospital - Center of Emergency Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects enrolled in the trial are patients, who will undergo standard diagnostic workup for chronic coronary syndromes (including standard procedures according to valid 2019 ESC guidelines, i.e. medical history for ischaemic heart disease, CCTA, and ICA with FFR as indicated) as a part of health care services.

Description

Inclusion Criteria:

  1. Age ≥ 18
  2. Declaration of informed consent to sharing medical records gathered during the standard diagnostic workup
  3. History of chronic coronary syndromes (CCS)
  4. Diagnostic CCTA (good quality test allowing investigation of the entire coronary artery tree), showing at least one site with stenosis ≥50% of the lumen in a large coronary artery of ≥ 2 mm diameter, with no prior revascularisation
  5. Standard treatment of chronic coronary syndromes with no dosage modification required within at least 4 weeks before the enrolment

  6. Patients with a prior acute coronary syndrome (ACS) or revascularisation would be found eligible under the following conditions:

    • Over 30 days from the acute coronary syndrome occurrence
    • FFR assessment during ICA may only cover the vessels that were not revascularized (both PCI and CABG) and were not the reason of ACS
    • No closed coronary arteries

Exclusion Criteria:

  1. CCTA-confirmed myocardial bridges causing >50% stenosis of the epicardial vascular lumen
  2. Coronary obstruction confirmed by CCTA or invasive coronarography
  3. History of ACS with coronary angioplasty or Coronary Artery Bypass Grafting (CABG) performed unless point 6 conditions are met
  4. Significant haemodynamic abnormalities of the valve or history of surgical correction of the defect or CABG
  5. Second-degree or third-degree atrioventricular block, sinus node dysfunction, QTc > 450 ms or prolonged QTc
  6. LVEF ≤ 35% found in an echocardiogram performed within the last 6 months
  7. BMI ≥ 35
  8. Clinically apparent infection
  9. Thrombocytopenia below 100.000/mm3
  10. Active neoplastic disease (apart from basal cell carcinoma and carcinoma in situ) and other conditions, which, in the investigator's opinion significantly affect their life expectancy
  11. Other significant conditions, infections, addictions and psychological or social factors, which, in the doctor's opinion, may affect patient's ability to participate in the trial or significantly affect their safety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard of care: FFR, ICA, CCTA
Patients with medical history for ischaemic heart disease will take part in non-invasive determination of haemodynamic parameters in coronary arteries with Cardiolens FFR-CT Pro technology.
Procedure: CCTA (Coronary Computed Tomography Angiography)
Per the protocol, patients had a coronary computed tomography angiography within standard of care before the enrollment to the study.
Procedure: ICA (Invasive Coronary Angiography)
Per the protocol, patients will have an Invasive Coronary Angiography within standard of care.
Procedure: FFR (Fractional Flow Reserve)
Per the protocol, patients will have a Fractional Flow Reserve procedure within standard of care.
Device: CNBP measurement
Per the protocol, patients will have the measurement of the resting Continuous Non-Invasive Blood Pressure (CNBP). The signal is required for iSIL-FFR technology.
Device: Cardiolens FFR-CT Pro
Per the protocol, non-invasive FFR measurements will be perfomed via Cardiolens FFR-CT Pro technology for the enrolled patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of the increased diagnostic accuracy of the non-invasive Cardiolens FFR-CT Pro technology
Time Frame: Up to 18 months
Evaluation of the increased diagnostic accuracy (area under ROC curve, AUC) in detection of haemodynamically significant stenoses in coronary arteries with a non-invasive Cardiolens FFR-CT Pro technology compared to CCTA in reference to the invasive fractional flow reserve (FFR) testing at the arterial level.
Up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of diagnostic accuracy of the non-invasive Cardiolens FFR-CT Pro technology
Time Frame: Up to 18 months
Evaluation of diagnostic accuracy of Cardiolens FFR-CT Pro in detection of haemodynamically significant stenoses in coronary arteries (FFR value ≤0.80) compared to CCTA (stenosis ≥ 50%), in reference to the invasive FFR testing at the patient and arterial level, based on parameters like sensitivity, specificity, positive/negative predictive value, accuracy at the patient and arterial level.
Up to 18 months
The evaluation of safety of the non-invasive Cardiolens FFR-CT Pro technology
Time Frame: Up to 5 days. The date from admission for the scheduled ICA to discharge from the hospital.

Evaluation of safety of the non-invasive Cardiolens FFR-CT Pro technology (the result of the non-invasive test completes the diagnostic workup for coronary disease) compared to the standard diagnostics in chronic coronary syndromes based on the following parameters:

  1. Radiation dose during the diagnostic workup
  2. Contrast medium dose in the diagnostic workup
  3. Adverse events during the diagnostic workup
  4. Duration of the diagnostic workup
Up to 5 days. The date from admission for the scheduled ICA to discharge from the hospital.
The evaluation of the costs of Cardiolens FFR-CT Pro technology
Time Frame: Up to 5 days. The date from admission for the scheduled ICA to discharge from the hospital.
3) Evaluation of the costs of Cardiolens FFR-CT Pro in diagnostics of chronic coronary syndromes compared to the standard diagnostic workup (the sum of the costs for individual diagnostic modalities according to the National Health Fund reimbursement prices as well as Procedural Reimbursement Payment Guide)
Up to 5 days. The date from admission for the scheduled ICA to discharge from the hospital.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hemolens Diagnostics Sp. z o.o.

Collaborators

GENELYTICA Sp. z o.o.

Investigators

  • Principal Investigator: Cezary Kępka, MD, PhD, The National Institute of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMOFLOW PMS_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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