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

Observational Clinical Trial

— FACC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03548753
• Other study ID #: HM19501968
• Status: Completed
• Start date: September 2, 2016
• Est. completion date: April 2018

Study information

• Verified date: June 2018
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Observational

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (10)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nørgaard 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, Bøtker 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. — View Citation

Nørgaard 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, Bøtker 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	90 days after inclusion
Secondary	Coronary revascularization procedures	Percentage of coronary revascularization procedures (PCI and CABG) in patients with reduced FFR-CT vs. patients with normal FFR-CT	90 day after inclusion
Secondary	Other clinical endpoints	Percentage of patients with the composite endpoint of all-cause mortality or myocardial infarction or unstable angina hospitalization	90 days after inclusion
Secondary	Major complications from diagnostic invasive diagnostic procedures	Percentage of patients with major complications following invasive coronary angiography (ICA) including fractional flow reserve (FFR) measurement	Within 72 hours after invasive procedure
Secondary	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	At least 90 days after patient inclusion
Secondary	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	At least 90 days after patient inclusion
Secondary	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)	At least 90 days after patient inclusion
Secondary	Costs and resource use.	Estimating the total costs of potentially unnecessary invasive coronary angiographies with functional flow ratio measurements	90 days after inclusion