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

NCT03548753 | Completed

• 1 other identifier: HM19501968
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Observational

Keywords

Angina; Chest pain; Diagnostic tests

Outcome Measures

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)

  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)

  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)

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

  90 days after inclusion

• Coronary revascularization procedures

  90 day after inclusion

• Other clinical endpoints

  90 days after inclusion

• Major complications from diagnostic invasive diagnostic procedures

  Within 72 hours after invasive procedure

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

  At least 90 days after patient inclusion

Study Arms (1)

Patients with Agatston score > 399

1. Coronary computed tomography angiography with FFR-CT 2. Invasive coronary angiography with FFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Odense C, 5000, Denmark

Location

Related Publications (11)

• 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.

  PMID: 28412436 BACKGROUND

• 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.

  PMID: 24890534 BACKGROUND

• 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.

  PMID: 23932641 BACKGROUND

• 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.

  PMID: 24290567 BACKGROUND

• 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.

  PMID: 16781246 BACKGROUND

• 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.

  PMID: 22032711 BACKGROUND

• 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.

  PMID: 24486266 BACKGROUND

• 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.

  PMID: 26298072 BACKGROUND

• 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.

  PMID: 25937196 BACKGROUND

• 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.

  PMID: 24890527 BACKGROUND

• 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.

  PMID: 35680213 DERIVED

MeSH Terms

Conditions

Angina Pectoris; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans Mickley, MD

  Professor, MD, DMSc

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (chair), MD

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 7, 2018
• Study Start: September 2, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)