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ObservationalFACCNCT03548753

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

An observational study of Observational, run by Odense University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Observational
How many people
278 participants
Where
1 siteDenmark
Study dates
2 Sep 2016to Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Renal Insufficiency (<40 mL/min)
  • Known anaphylactic reaction to iodinated contrast
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Odense University Hospital

    Odense, Odense C, 5000

Other trials in Denmark

About this study

Official title: Functional and Anatomical Testing in Intermediate Risk 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.

Read the 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.

Conditions
Observational
Keywords
Angina, Chest pain, Diagnostic tests
Medical subject headings
Angina Pectoris, Chest Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03548753
Study groupRoleWhat they receive
Patients with Agatston score > 3991. Coronary computed tomography angiography with FFR-CT 2. Invasive coronary angiography with FFR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    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)

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

Secondary outcomes (8)

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

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

    Measured: 90 days after inclusion

  2. Coronary revascularization procedures

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

    Measured: 90 day after inclusion

  3. Other clinical endpoints

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

    Measured: 90 days after inclusion

  4. Major complications from diagnostic invasive diagnostic procedures

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

    Measured: Within 72 hours after invasive procedure

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

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

    Measured: At least 90 days after patient inclusion

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

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

    Measured: At least 90 days after patient inclusion

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

    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)

    Measured: At least 90 days after patient inclusion

  8. Costs and resource use.

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

    Measured: 90 days after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2018
  2. Study start2 Sep 2016
  3. Primary completionApr 2018
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03548753
Sponsor's protocol ID
HM19501968
Acronym
FACC
Status last verified
Jun 2018
First submitted
22 May 2018
Last updated
15 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lu MT, Ferencik M, Roberts RS, Lee KL, Ivanov A, Adami E, Mark DB, Jaffer FA, Leipsic JA, Douglas PS, Hoffmann U. Noninvasive FFR Derived From Coronary CT Angiography: Management and Outcomes in the PROMISE Trial. JACC Cardiovasc Imaging. 2017 Nov;10(11):1350-1358. doi: 10.1016/j.jcmg.2016.11.024. Epub 2017 Apr 12.

    PubMed 28412436

  • Patel MR, Dai D, Hernandez AF, Douglas PS, Messenger J, Garratt KN, Maddox TM, Peterson ED, Roe MT. Prevalence and predictors of nonobstructive coronary artery disease identified with coronary angiography in contemporary clinical practice. Am Heart J. 2014 Jun;167(6):846-52.e2. doi: 10.1016/j.ahj.2014.03.001. Epub 2014 Mar 14.

    PubMed 24890534

  • Yan RT, Miller JM, Rochitte CE, Dewey M, Niinuma H, Clouse ME, Vavere AL, Brinker J, Lima JA, Arbab-Zadeh A. Predictors of inaccurate coronary arterial stenosis assessment by CT angiography. JACC Cardiovasc Imaging. 2013 Sep;6(9):963-72. doi: 10.1016/j.jcmg.2013.02.011. Epub 2013 Aug 8.

    PubMed 23932641

  • Kruk M, Noll D, Achenbach S, Mintz GS, Pregowski J, Kaczmarska E, Kryczka K, Pracon R, Dzielinska Z, Sleszycka J, Witkowski A, Demkow M, Ruzyllo W, Kepka C. Impact of coronary artery calcium characteristics on accuracy of CT angiography. JACC Cardiovasc Imaging. 2014 Jan;7(1):49-58. doi: 10.1016/j.jcmg.2013.07.013. Epub 2013 Nov 27.

    PubMed 24290567

  • Ong TK, Chin SP, Liew CK, Chan WL, Seyfarth MT, Liew HB, Rapaee A, Fong YY, Ang CK, Sim KH. Accuracy of 64-row multidetector computed tomography in detecting coronary artery disease in 134 symptomatic patients: influence of calcification. Am Heart J. 2006 Jun;151(6):1323.e1-6. doi: 10.1016/j.ahj.2005.12.027.

    PubMed 16781246

  • Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.

    PubMed 22032711

  • Norgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, Kaltoft A, Lassen JF, Botker HE, Achenbach S; NXT Trial Study Group. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 1;63(12):1145-1155. doi: 10.1016/j.jacc.2013.11.043. Epub 2014 Jan 30.

    PubMed 24486266

  • Norgaard BL, Gaur S, Leipsic J, Ito H, Miyoshi T, Park SJ, Zvaigzne L, Tzemos N, Jensen JM, Hansson N, Ko B, Bezerra H, Christiansen EH, Kaltoft A, Lassen JF, Botker HE, Achenbach S. Influence of Coronary Calcification on the Diagnostic Performance of CT Angiography Derived FFR in Coronary Artery Disease: A Substudy of the NXT Trial. JACC Cardiovasc Imaging. 2015 Sep;8(9):1045-1055. doi: 10.1016/j.jcmg.2015.06.003. Epub 2015 Aug 19.

    PubMed 26298072

  • Hecht HS. Coronary artery calcium scanning: past, present, and future. JACC Cardiovasc Imaging. 2015 May;8(5):579-596. doi: 10.1016/j.jcmg.2015.02.006.

    PubMed 25937196

  • Douglas PS, Hoffmann U, Lee KL, Mark DB, Al-Khalidi HR, Anstrom K, Dolor RJ, Kosinski A, Krucoff MW, Mudrick DW, Patel MR, Picard MH, Udelson JE, Velazquez EJ, Cooper L; PROMISE investigators. PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial. Am Heart J. 2014 Jun;167(6):796-803.e1. doi: 10.1016/j.ahj.2014.03.003. Epub 2014 Mar 18.

    PubMed 24890527

  • Mickley H, Veien KT, Gerke O, Lambrechtsen J, Rohold A, Steffensen FH, Husic M, Akkan D, Busk M, Jessen LB, Jensen LO, Diederichsen A, Ovrehus KA. Diagnostic and Clinical Value of FFRCT in Stable Chest Pain Patients With Extensive Coronary Calcification: The FACC Study. JACC Cardiovasc Imaging. 2022 Jun;15(6):1046-1058. doi: 10.1016/j.jcmg.2021.12.010. Epub 2022 Feb 16.

    PubMed 35680213

Questions about this trial

What is this clinical trial studying?

An observational study of Observational, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03548753, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.

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