Role of On-site CT-derived FFR in the Management of Suspect CAD Patients

NCT03901326 | Completed Results DMC

• 1 other identifier: S2019-025-01
• Study Type: interventional
• Target: 1,216
• Locations: 1 country
• Sites: 1

Brief Summary

The primary of this registry is to evaluate whether the availability of CTA/CT-FFR procedure could effectively optimize the flow of clinical practice of stable chest pain versus conventional clinical pathway in decision making, avoid the overuse of invasive procedure, finally improve clinical prognosis and reduce total medical expenditure. This registry is randomized, open labeled, prospective designed and will be performed in 6 Chinese hospitals. Approximately 1200 subjects will be enrolled and subsequently assigned to either routine clinically-indicated diagnostic care group (CID arm) or CTA/CT-FFR care group (CTA/CT-FFR arm) via computer-generated random numbers (1:1 ratio)

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Coronary computed tomographic angiography; Fractional flow reserve

Outcome Measures

Primary Outcomes (1)

• Number of Participants With ICA Without Obstructive CAD or Intervention

  Number of those patients with planned ICA in whom no significant obstructive CAD (no stenosis≥70% by core lab quantitative analysis or invasive FFR≤0.8) is found or interventions (including stent implantation, balloon dilation and bypass graft) are performed during ICA within 90 days.

  90 days

Secondary Outcomes (4)

• Number of Participant With Major Adverse Cardiovascular Event

  12 months

• Medical Expenditure

  12 months

• Patient Reporting Outcomes

  Study entry, 3 months, 6 months and12 months

• Cumulative Radiation Exposure

  90 days, 12 months

Study Arms (2)

CTA/CT-FFR care group

EXPERIMENTAL

If the subjects are randomly allocated to CT-FFR arm, they will be examined by on-site DeepFFR for three major epicardial coronary arteries. If the result of CT-FFR calculation is less than or equal to 0.8 in one or more major coronary arteries, the patient will be referred to ICA directly; if the result of CT-FFR value is more than 0.8, optimal medical therapy will be recommended. The decision on the mode of revascularization is left to the treating cardiologists and depends on local practice standard.

Diagnostic Test: CT-FFR assessment

Routine clinically-indicated diagnostic care group

NO INTERVENTION

If the subjects are randomized to usual care arm, attending physicians will decide the next step of diagnosis and treatment, such as exercise ECG, stress cardiac echo, cardiac MR, and SPECT. According to the results of examination combined with risk factors assessment and clinical manifestations, physicians should provide recommendation whether the subjects would undergo ICA or not.

Interventions

CT-FFR assessment DIAGNOSTIC_TEST

When subjects are randomized to the CTA/CT-FFR arm, FFR based on the coronary CTA imaging will be measured. DEEPVESSEL FFR workstation is very dedicated software utilizing the original CTA imaging to meter simulated FFR values based on a machine learning algorithm. The first step is to extract a 3D coronary artery model and generate coronary centerlines which are similar to the routine reconstruction of coronary CTA. The centerlines are extracted using a minimal path extraction filter. Then a novel path-based deep learning model, referred to DEEPVESSEL FFR, is used to predict the simulated FFR values on the vascular centerlines. Deep learning algorithm is used to establish characteristic sample database of coronary hemodynamics characteristic parameters. When deep training model is proved to be valid, it is applied to a new lesion-specific measurement. Lesion-specific CT-FFR is defined as simulated FFR value at distance of 20mm away from the lesion of interest.

CTA/CT-FFR care group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New-onset chest pain suspicious for CAD
• Coronary CTA result showed that the diameter stenosis is between 30 and 90% in at least one major coronary artery (coronary artery diameter ≥ 2.5 mm)
• Intermediate-to-high pretest probability of CAD based on CAD Consortium Score
• No prior evaluation for this episode of symptoms
• Agree to participate in this clinical study and sign written informed consent

You may not qualify if:

• Diagnosed or suspected acute coronary syndrome requiring hospitalization or emergent testing
• Hemodynamically or clinically unstable condition systolic blood pressure \< 90 mmHg or serious atrial or ventricular arrhythmias
• Known CAD with prior myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), or any angiographic evidence of ≥ 50% stenosis in any major coronary artery
• Patients with left main branch stenosis ≥ 50% or major coronary artery stenosis \> 90%
• Known severe congenital, valvular (moderate and above), or cardiomyopathy process (hypertrophic cardiomyopathy or reduced systolic left ventricular function ≤ 40%) which could explain cardiac symptoms
• Unable to provide written informed consent or participate in long-term follow-up.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Anzhen Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Tongji Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (12)

• Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.

  PMID: 22922562 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

• Douglas PS, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, Hlatky MA; PLATFORM Investigators. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057.

  PMID: 27470449 BACKGROUND

• Fairbairn TA, Nieman K, Akasaka T, Norgaard BL, Berman DS, Raff G, Hurwitz-Koweek LM, Pontone G, Kawasaki T, Sand NP, Jensen JM, Amano T, Poon M, Ovrehus K, Sonck J, Rabbat M, Mullen S, De Bruyne B, Rogers C, Matsuo H, Bax JJ, Leipsic J, Patel MR. Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry. Eur Heart J. 2018 Nov 1;39(41):3701-3711. doi: 10.1093/eurheartj/ehy530.

  PMID: 30165613 BACKGROUND

• Norgaard BL, Hjort J, Gaur S, Hansson N, Botker HE, Leipsic J, Mathiassen ON, Grove EL, Pedersen K, Christiansen EH, Kaltoft A, Gormsen LC, Maeng M, Terkelsen CJ, Kristensen SD, Krusell LR, Jensen JM. Clinical Use of Coronary CTA-Derived FFR for Decision-Making in Stable CAD. JACC Cardiovasc Imaging. 2017 May;10(5):541-550. doi: 10.1016/j.jcmg.2015.11.025. Epub 2016 Apr 13.

  PMID: 27085447 BACKGROUND

• Colleran R, Douglas PS, Hadamitzky M, Gutberlet M, Lehmkuhl L, Foldyna B, Woinke M, Hink U, Nadjiri J, Wilk A, Wang F, Pontone G, Hlatky MA, Rogers C, Byrne RA. An FFRCT diagnostic strategy versus usual care in patients with suspected coronary artery disease planned for invasive coronary angiography at German sites: one-year results of a subgroup analysis of the PLATFORM (Prospective Longitudinal Trial of FFRCT: Outcome and Resource Impacts) study. Open Heart. 2017 Mar 22;4(1):e000526. doi: 10.1136/openhrt-2016-000526. eCollection 2017.

  PMID: 28674617 BACKGROUND

• Collet C, Onuma Y, Andreini D, Sonck J, Pompilio G, Mushtaq S, La Meir M, Miyazaki Y, de Mey J, Gaemperli O, Ouda A, Maureira JP, Mandry D, Camenzind E, Macron L, Doenst T, Teichgraber U, Sigusch H, Asano T, Katagiri Y, Morel MA, Lindeboom W, Pontone G, Luscher TF, Bartorelli AL, Serruys PW. Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease. Eur Heart J. 2018 Nov 1;39(41):3689-3698. doi: 10.1093/eurheartj/ehy581.

  PMID: 30312411 BACKGROUND

• Norgaard BL, Terkelsen CJ, Mathiassen ON, Grove EL, Botker HE, Parner E, Leipsic J, Steffensen FH, Riis AH, Pedersen K, Christiansen EH, Maeng M, Krusell LR, Kristensen SD, Eftekhari A, Jakobsen L, Jensen JM. Coronary CT Angiographic and Flow Reserve-Guided Management of Patients With Stable Ischemic Heart Disease. J Am Coll Cardiol. 2018 Oct 30;72(18):2123-2134. doi: 10.1016/j.jacc.2018.07.043. Epub 2018 Aug 25.

  PMID: 30153968 BACKGROUND

• Jensen JM, Botker HE, Mathiassen ON, Grove EL, Ovrehus KA, Pedersen KB, Terkelsen CJ, Christiansen EH, Maeng M, Leipsic J, Kaltoft A, Jakobsen L, Sorensen JT, Thim T, Kristensen SD, Krusell LR, Norgaard BL. Computed tomography derived fractional flow reserve testing in stable patients with typical angina pectoris: influence on downstream rate of invasive coronary angiography. Eur Heart J Cardiovasc Imaging. 2018 Apr 1;19(4):405-414. doi: 10.1093/ehjci/jex068.

  PMID: 28444153 BACKGROUND

• Yang J, Shan D, Wang X, Sun X, Shao M, Wang K, Pan Y, Wang Z, Schoepf UJ, Savage RH, Zhang M, Dong M, Xu L, Zhou Y, Ma X, Hu X, Xia L, Zeng H, Liu Z, Chen Y. On-Site Computed Tomography-Derived Fractional Flow Reserve to Guide Management of Patients With Stable Coronary Artery Disease: The TARGET Randomized Trial. Circulation. 2023 May 2;147(18):1369-1381. doi: 10.1161/CIRCULATIONAHA.123.063996. Epub 2023 Mar 4.

  PMID: 36870065 DERIVED

• Yang J, Shan D, Dong M, Wang Z, Ma X, Hu X, Zeng H, Chen Y. The effect of on-site CT-derived fractional flow reserve on the management of decision making for patients with stable chest pain (TARGET trial): objective, rationale, and design. Trials. 2020 Aug 20;21(1):728. doi: 10.1186/s13063-020-04649-9.

  PMID: 32819429 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr Junjie Yang
• Organization: People's Liberation Army General Hospital

fearlessyang@126.com

13581662680

Study Officials

• Yundai Chen, Ph.D.

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology Department

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 3, 2019
• Study Start: May 10, 2019
• Primary Completion: October 30, 2022
• Study Completion: October 31, 2022
• Last Updated: May 31, 2024
• Results First Posted: May 31, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)