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.

NCT04777513 | Completed FDA Device

• 1 other identifier: HEMOFLOW PMS_2020
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Stable Ischemic Heart Disease; Coronary Artery Disease

Keywords

Fractional Flow Reserve; Chronic Coronary Syndromes; Coronary Artery lesions; Vascular Diseases; Post-market surveillance; Invasive Coronary Angiography; Coronary Computed Tomography Angiography

Outcome Measures

Primary Outcomes (1)

• The evaluation of the increased diagnostic accuracy of the non-invasive Cardiolens FFR-CT Pro technology

  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 Outcomes (3)

• The evaluation of diagnostic accuracy of the non-invasive Cardiolens FFR-CT Pro technology

  Up to 18 months

• The evaluation of safety of the non-invasive Cardiolens FFR-CT Pro technology

  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

  Up to 5 days. The date from admission for the scheduled ICA to discharge from the hospital.

Study Arms (1)

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); Procedure: ICA (Invasive Coronary Angiography); Procedure: FFR (Fractional Flow Reserve); Device: CNBP measurement; Device: Cardiolens FFR-CT Pro

Interventions

CCTA (Coronary Computed Tomography Angiography) PROCEDURE

Per the protocol, patients had a coronary computed tomography angiography within standard of care before the enrollment to the study.

Standard of care: FFR, ICA, CCTA

ICA (Invasive Coronary Angiography) PROCEDURE

Per the protocol, patients will have an Invasive Coronary Angiography within standard of care.

Standard of care: FFR, ICA, CCTA

FFR (Fractional Flow Reserve) PROCEDURE

Per the protocol, patients will have a Fractional Flow Reserve procedure within standard of care.

Standard of care: FFR, ICA, CCTA

CNBP measurement DEVICE

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.

Standard of care: FFR, ICA, CCTA

Cardiolens FFR-CT Pro DEVICE

Per the protocol, non-invasive FFR measurements will be perfomed via Cardiolens FFR-CT Pro technology for the enrolled patients.

Standard of care: FFR, ICA, CCTA

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Declaration of informed consent to sharing medical records gathered during the standard diagnostic workup
• History of chronic coronary syndromes (CCS)
• 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
• Standard treatment of chronic coronary syndromes with no dosage modification required within at least 4 weeks before the enrolment
• 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

You may not qualify if:

• CCTA-confirmed myocardial bridges causing \>50% stenosis of the epicardial vascular lumen
• Coronary obstruction confirmed by CCTA or invasive coronarography
• History of ACS with coronary angioplasty or Coronary Artery Bypass Grafting (CABG) performed unless point 6 conditions are met
• Significant haemodynamic abnormalities of the valve or history of surgical correction of the defect or CABG
• Second-degree or third-degree atrioventricular block, sinus node dysfunction, QTc \> 450 ms or prolonged QTc
• LVEF ≤ 35% found in an echocardiogram performed within the last 6 months
• BMI ≥ 35
• Clinically apparent infection
• Thrombocytopenia below 100.000/mm3
• 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
• 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

Sponsors & Collaborators

• Hemolens Diagnostics Sp. z o.o.: lead
• GENELYTICA Sp. z o.o.: collaborator

Study Sites (11)

American Heart of Poland, Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej

Bielsko-Biala, 43-316, Poland

Location

The University Clinical Centre

Gdansk, Poland

Location

The Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University

Katowice, Poland

Location

Oddział Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

Location

The John Paul II Specialist Hospital in Cracovia

Krakow, 31-202, Poland

Location

"Miedziowe Centrum Zdrowia" S.A.

Lubin, 59-301, Poland

Location

American Heart of Poland, Centrum Sercowo - Naczyniowe w Ustroniu

Ustroń, 43-450, Poland

Location

The Cardinal Stefan Wyszyński National Institute of Cardiology

Warsaw, Poland

Location

The 4th Military Teaching Hospital

Wroclaw, Poland

Location

The Jan Mikulicz-Radecki University Teaching Hospital

Wroclaw, Poland

Location

The T. Marciniak Lower Silesian Specialist Hospital - Center of Emergency Medicine

Wroclaw, Poland

Location

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Related Links

• WHO Fact sheet N°317 September 2012
• WHO Fact sheet N°310 Updated June 2011
• Related Info
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MeSH Terms

Conditions

Coronary Artery Disease; Vascular Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Cezary Kępka, MD, PhD

  The National Institute of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: March 2, 2021
• Study Start: August 6, 2020
• Primary Completion: September 30, 2022
• Study Completion: May 31, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

PL (11)