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NCT Number: NCT03548753

Use of FFR-CT in Stable Intermediate Chest Pain Patients With Severe Coronary Calcium Score

A prospective, blinded multicenter study for evaluation of chest pain patients with severe coronary calcium (Agatston score > 399). The objective is to evaluate if an initial non-invasive strategy with coronary computed tomography angiography (CCTA) including functional flow reserve derived from CCTA (FFR-CT) is as effective as invasive coronary angiography (ICA) including functional flow reserve (FFR) for the detection and exclusion of obstructive coronary artery disease (CAD). Study hypothesis: initial non-invasive anatomic and functional testing is non-inferior to an invasive anatomic and functional testing strategy.

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Key information

Conditions

Observational Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital

Odense, Odense C, 5000, Denmark

About this study

Prospective, blinded multicenter study evaluating the diagnostic performance of coronary computed tomography angiography (CCTA) including functional flow reserve derived from CCTA (FFR-CT) for the detection and exclusion of significant obstructive coronary artery disease (CAD). The reference standard vil be invasive coronary angiography (ICA) including functional flow reserve (FFR). Patients referred for elective CCTA because of suspected stable CAD are considered. If the initial routine non-enhanced CT scan shows an Agatston score > 399, the patient is eligible for study inclusion. Four sites in the region of Southern Denmark will participate (Odense University Hospital, Svendborg Hospital, Vejle Hospital and Esbjerg Hospital). A total of 278 patients will be included.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • An estimated likelihood for the presence of significant CAD between 15% and 85%
  • Clinical stable patients with symptoms of suspected CAD referred for CTTA
  • Initial routine non-enhanced CT scan shows an Agatston score >399
  • Written informed consent
  • Accept to undergo elective invasive coronary angiography (ICA) within 90 days

Exclusion criteria

  • Known prior myocardial infarction
  • Prior percutaneous coronary intervention (PCI)
  • Prior coronary artery bypass surgery (CABG)
  • Pacemaker or internal defibrillator lead implantation
  • Prosthetic heart valve
  • Atrial fibrillation
  • Renal Insufficiency (<40 mL/min)
  • Known anaphylactic reaction to iodinated contrast
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Per-patient diagnostic accuracy of functional flow reserve (FFR-CT) derived from standard coronary computed tomography angiography (CCTA) compared to invasive coronary angiography (ICA) including functional flow ratio (FFR)

    Time frame: Comparison of the noninvasive and invasive diagnostic modalities is performed at least 90 days after enrollment of each of the included patients

    The primary outcome measure is the per-patient diagnostic accuracy of functional flow reserve (FFR-CT) derived from standard coronary computed tomography angiography (CCTA) compared to invasive coronary angiography (ICA) including functional flow ratio (FFR), which is considered the gold standard in the detection or exclusion of obstructive coronary artery disease (CAD)

Secondary outcomes

  1. Invasive coronary angiography (ICA) including functional flow ratio (FFR) without obstructive coronary artery disease

    Time frame: 90 days after inclusion

    Percentage of patients with invasive coronary angiography (ICA) including functional flow reserve (FFR) measurement without evidence of obstructive coronary artery disease

  2. Coronary revascularization procedures

    Time frame: 90 day after inclusion

    Percentage of coronary revascularization procedures (PCI and CABG) in patients with reduced FFR-CT vs. patients with normal FFR-CT

  3. Other clinical endpoints

    Time frame: 90 days after inclusion

    Percentage of patients with the composite endpoint of all-cause mortality or myocardial infarction or unstable angina hospitalization

  4. Major complications from diagnostic invasive diagnostic procedures

    Time frame: Within 72 hours after invasive procedure

    Percentage of patients with major complications following invasive coronary angiography (ICA) including fractional flow reserve (FFR) measurement

  5. Per-patient and per-vessel diagnostic performance of FFR-CT by means of accuracy, sensitivity, specificity, positive predictive value, and negative predictive value

    Time frame: At least 90 days after patient inclusion

    Assessing per-patient and per-vessel diagnostic performance of FFR-CT by means of accuracy, sensitivity, specificity, positive predictive value, and negative predictive value

  6. Per-vessel correlation of FFR-CT numerical value with the FFR numerical value in patients undergoing FFR

    Time frame: At least 90 days after patient inclusion

    The per-vessel correlation of FFRCT numerical value with the FFR numerical value in patients undergoing FFR

  7. The diagnostic accuracy of FFR-CT in subgroups of patients with high calcium score vs. patients with very high calcium score

    Time frame: At least 90 days after patient inclusion

    Comparison of the diagnostic accuracy of FFR-CT in subgroups of patients with high calcium score (Agatston score 400-999) vs patients with very high calcium score (Agatston score ≥ 999)

  8. Costs and resource use.

    Time frame: 90 days after inclusion

    Estimating the total costs of potentially unnecessary invasive coronary angiographies with functional flow ratio measurements

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Functional and Anatomical Testing in Intermediate Risk Chest Pain Patients With Severe Coronary Calcium Score

Acronym: FACC

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2018
Registry last updated
Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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