Use of FFR-CT in Stable Intermediate Chest Pain Patients With Severe Coronary Calcium Score
NCT ID: NCT03548753
Last Updated: 2018-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
278 participants
OBSERVATIONAL
2016-09-02
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with Agatston score > 399
1. Coronary computed tomography angiography with FFR-CT
2. Invasive coronary angiography with FFR
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Hans Mickley
Professor (chair), MD
Principal Investigators
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Hans Mickley, MD
Role: STUDY_CHAIR
Professor, MD, DMSc
Locations
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Odense University Hospital
Odense, Odense C, Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HM19501968
Identifier Type: -
Identifier Source: org_study_id
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