Coronary Computed Tomographic Angiography Combined With CT-FFR in Intermediate-Risk Chest Pain Patients.

NCT07140419 | Not Yet Recruiting

• 1 other identifier: KYLL-202412(XZ)-014-3
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the guiding value of coronary CTA combined with CT-FFR in diagnostic and treatment decision-making for emergency chest pain patients at moderate risk, as well as its impact on clinical outcomes. Through a prospective multicenter randomized controlled trial, this research compares the preventive effects of early application of this technology versus standard care on major adverse cardiovascular and cerebrovascular events (MACCE), with the goal of optimizing the diagnostic and treatment processes for emergency chest pain patients.

Conditions

Chest Pain; Coronary Artery Disease; Emergency Department

Keywords

Intermediate Risk Chest Pain; Emergency Department; CCTA; CT-FFR; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of Major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina pectoris

  Major adverse cardiovascular and cerebrovascular events (MACCE), a pivotal composite endpoint in cardiovascular clinical trials, are defined as the aggregate occurrence of cardiovascular death, nonfatal ST - elevation or non - ST - elevation myocardial infarction (reflecting ischemic myocardial injury), nonfatal ischemic or hemorrhagic stroke (denoting cerebrovascular ischemia or hemorrhage), coronary revascularization (encompassing percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\] for obstructive coronary lesions), and unstable angina pectoris (characterized by new - onset or crescendo chest pain indicative of acute coronary syndrome without myocardial necrosis).

  The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.

Secondary Outcomes (9)

• Incidence of Recurrent Emergency Department Visit for Chest Pain

  The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled

• Hospitalization Rate due to Chest Pain or Stroke

  1 month; the enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled

• Incidence of All-cause mortality

  The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.

• Proportion of Patients Undergoing Invasive Coronary Angiography

  The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.

• Proportion of Patients with Non-Obstructive CAD at Invasive Coronary Angiography

  The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.

Other Outcomes (2)

• Number of Participants with Allergic Reactions or Anaphylaxis within 24 Hours Post-CCTA or Invasive Coronary Angiography

  Within 24 hours of CCTA or invasive coronary angiography

• Number of Participants with Acute Liver or Kidney Injury within 7 Days Post-CCTA or Invasive Coronary Angiography

  Within 7 days of CCTA or invasive coronary angiography

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Patients receive early coronary computed tomographic angiography (CCTA) combined with CT-derived fractional flow reserve (CT-FFR) to guide diagnostic and treatment decisions, in addition to standard care.

Diagnostic Test: Coronary computed tomographic angiography with CT - derived fractional flow reserve

Control Arm

NO INTERVENTION

Patients receive standard care without early CCTA, with further management determined at the discretion of their treating physician.

Interventions

Coronary computed tomographic angiography with CT - derived fractional flow reserve DIAGNOSTIC_TEST

A non-invasive coronary computed tomography angiography (CCTA) protocol that visualizes coronary anatomy to evaluate the presence, location, and severity of atherosclerotic stenosis, coupled with CT-derived fractional flow reserve (CT-FFR) analysis-a computational fluid dynamics method applied to CCTA datasets-to assess the hemodynamic significance of identified stenoses and identify lesions likely to induce myocardial ischemia.

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• Age≥18 years；
• Within 24 hours of presenting to the emergency department (ED) with chest pain or other symptoms suggestive of coronary artery disease (CAD)；
• HEART-score \>3 (according to http://www.heartscore.nl/)；
• Signed written informed consent.

You may not qualify if:

• Inability to obtain informed consent；
• Acute Coronary Syndromes (ACS) requiring urgent revascularization；
• Known Obstructive Coronary Artery Disease (CAD) or previous PCI or CABG;
• Concomitant severe congestive heart failure (New York Heart Association \[NYHA\] class III-IV or left ventricular ejection fraction \[LVEF\] \< 30%) or acute pulmonary edema;
• Severe hepatic insufficiency (Child-Pugh score ≥ C, or aspartate aminotransferase \[AST\] \> 5× upper limit of normal); severe renal insufficiency (estimated glomerular filtration rate \[eGFR\] ≤ 30 mL/min/1.73 m²) or patients receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis;
• History of prior coronary artery bypass grafting (CABG);
• Severe allergy to iodinated contrast agents;
• Inability to obtain high-quality imaging;
• Pregnant or lactating females;
• Concomitant diseases or limited life expectancy, quality of life, or functional status precluding further CAD evaluation;
• Any other factors that, in the investigator's judgment, make the patient unsuitable for study enrollment, completion of the study, or follow-up.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Beijing Anzhen Hospital: collaborator
• JiNing NO.1 People Hospital: collaborator
• Zhun Ge Er Qi Central Hospital: collaborator
• Qilu Hospital of Shandong University: lead
• The Affiliated Hospital of Qingdao University: collaborator

Study Sites (1)

Chuanbao Li

Jinan, Shandong, 250000, China

Location

Related Publications (10)

• Gulati M, Levy PD, Mukherjee D, Amsterdam E, Bhatt DL, Birtcher KK, Blankstein R, Boyd J, Bullock-Palmer RP, Conejo T, Diercks DB, Gentile F, Greenwood JP, Hess EP, Hollenberg SM, Jaber WA, Jneid H, Joglar JA, Morrow DA, O'Connor RE, Ross MA, Shaw LJ. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Nov 30;144(22):e368-e454. doi: 10.1161/CIR.0000000000001029. Epub 2021 Oct 28.

  PMID: 34709879 BACKGROUND

• Hoffmann U, Truong QA, Schoenfeld DA, Chou ET, Woodard PK, Nagurney JT, Pope JH, Hauser TH, White CS, Weiner SG, Kalanjian S, Mullins ME, Mikati I, Peacock WF, Zakroysky P, Hayden D, Goehler A, Lee H, Gazelle GS, Wiviott SD, Fleg JL, Udelson JE; ROMICAT-II Investigators. Coronary CT angiography versus standard evaluation in acute chest pain. N Engl J Med. 2012 Jul 26;367(4):299-308. doi: 10.1056/NEJMoa1201161.

  PMID: 22830462 BACKGROUND

• Gongora CA, Bavishi C, Uretsky S, Argulian E. Acute chest pain evaluation using coronary computed tomography angiography compared with standard of care: a meta-analysis of randomised clinical trials. Heart. 2018 Feb;104(3):215-221. doi: 10.1136/heartjnl-2017-311647. Epub 2017 Aug 30.

  PMID: 28855273 BACKGROUND

• Foy AJ, Dhruva SS, Peterson B, Mandrola JM, Morgan DJ, Redberg RF. Coronary Computed Tomography Angiography vs Functional Stress Testing for Patients With Suspected Coronary Artery Disease: A Systematic Review and Meta-analysis. JAMA Intern Med. 2017 Nov 1;177(11):1623-1631. doi: 10.1001/jamainternmed.2017.4772.

  PMID: 28973101 BACKGROUND

• SCOT-HEART Investigators; Newby DE, Adamson PD, Berry C, Boon NA, Dweck MR, Flather M, Forbes J, Hunter A, Lewis S, MacLean S, Mills NL, Norrie J, Roditi G, Shah ASV, Timmis AD, van Beek EJR, Williams MC. Coronary CT Angiography and 5-Year Risk of Myocardial Infarction. N Engl J Med. 2018 Sep 6;379(10):924-933. doi: 10.1056/NEJMoa1805971. Epub 2018 Aug 25.

  PMID: 30145934 BACKGROUND

• Moss AJ, Williams MC, Newby DE, Nicol ED. The Updated NICE Guidelines: Cardiac CT as the First-Line Test for Coronary Artery Disease. Curr Cardiovasc Imaging Rep. 2017;10(5):15. doi: 10.1007/s12410-017-9412-6. Epub 2017 Mar 27.

  PMID: 28446943 BACKGROUND

• Goodacre S, Thokala P, Carroll C, Stevens JW, Leaviss J, Al Khalaf M, Collinson P, Morris F, Evans P, Wang J. Systematic review, meta-analysis and economic modelling of diagnostic strategies for suspected acute coronary syndrome. Health Technol Assess. 2013;17(1):v-vi, 1-188. doi: 10.3310/hta17010.

  PMID: 23331845 BACKGROUND

• Mowatt G, Cummins E, Waugh N, Walker S, Cook J, Jia X, Hillis GS, Fraser C. Systematic review of the clinical effectiveness and cost-effectiveness of 64-slice or higher computed tomography angiography as an alternative to invasive coronary angiography in the investigation of coronary artery disease. Health Technol Assess. 2008 May;12(17):iii-iv, ix-143. doi: 10.3310/hta12170.

  PMID: 18462576 BACKGROUND

• Ljung L, Lindahl B, Eggers KM, Frick M, Linder R, Lofmark HB, Martinsson A, Melki D, Sarkar N, Svensson P, Jernberg T. A Rule-Out Strategy Based on High-Sensitivity Troponin and HEART Score Reduces Hospital Admissions. Ann Emerg Med. 2019 May;73(5):491-499. doi: 10.1016/j.annemergmed.2018.11.039. Epub 2019 Jan 17.

  PMID: 30661856 BACKGROUND

• Shen C, Ge J. Epidemic of Cardiovascular Disease in China: Current Perspective and Prospects for the Future. Circulation. 2018 Jul 24;138(4):342-344. doi: 10.1161/CIRCULATIONAHA.118.033484. No abstract available.

  PMID: 30571361 BACKGROUND

MeSH Terms

Conditions

Chest Pain; Coronary Artery Disease; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes

Central Study Contacts

Chuanbao Li

CONTACT

+86 18560083097; bao2460@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Prior to outcome adjudication, all relevant documents will be de-identified to exclude any reference to prior coronary computed tomographic angiography (CCTA) results, ensuring evaluators remain blinded to baseline imaging data that could influence objective assessment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Patients presenting to the emergency department (ED) with chest pain or other symptoms suggestive of acute coronary syndrome (ACS), who have intermediate risk (defined by a HEART score \> 3) and no acute myocardial infarction (MI), will be randomized to one of two strategies after providing written informed consent: an initial approach involving coronary computed tomographic angiography (CCTA) or a standard care pathway without early CCTA.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 24, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2032
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)