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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03548753
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Hans Mickley, Odense University Hospital

Study Description
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Brief Summary:
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.

Condition or disease
Observational

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 278 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional and Anatomical Testing in Intermediate Risk Chest Pain Patients With Severe Coronary Calcium Score
Actual Study Start Date : September 2, 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Chest Pain

Groups and Cohorts
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Group/Cohort
Patients with Agatston score > 399
  1. Coronary computed tomography angiography with FFR-CT
  2. Invasive coronary angiography with FFR


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Clinical stable outpatients with symptoms of suspected coronary artery disease (CAD) referred for coronary computed tomography angiography (CCTA) as first-line noninvasive diagnostic test at one of the four participating centers are eligible for study inclusion, if the initial routine non-enhanced CT scan shows an Agatston score > 399.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548753


Locations
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Denmark
Odense University Hospital
Odense, Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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Study Chair: Hans Mickley, MD Professor, MD, DMSc
More Information
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Publications:

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Responsible Party: Hans Mickley, Professor (chair), MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03548753    
Other Study ID Numbers: HM19501968
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hans Mickley, Odense University Hospital:
Angina
Chest pain
Diagnostic tests
Additional relevant MeSH terms:
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Chest Pain
Pain
Neurologic Manifestations