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NCT05857904Not yet recruiting

Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

Clinical Outcomes of CoroNary CTA-Derived FFR Versus ICA-Derived QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

Source: ClinicalTrials.gov · Last updated 15 May 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study is a multicenter, prospective, blinded (blinding of clinical evaluators), randomized controlled, event-driven non-inferiority clinical trial. Eligible subjects who meet the inclusion criteria will be registered in the central randomization system and randomized in a 1:1 ratio to either the experimental group (CT-FFR guided group) or the control group (QFR guided group).

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
4648 (estimated)
First submitted
22 Apr 2023
Start date
May 2023
Primary completion date
May 2025
Lead sponsor
Shanghai Zhongshan Hospital
NCT number
NCT05857904

What you commit to

  • Study type: Interventional
  • Planned participants: 4648
  • From May 2023 to the primary completion date, May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with acute coronary syndrome requiring urgent revascularization.
  • Patients with unstable angina, including those with first-onset chest pain within 48 hours, CCS III or higher first-onset angina, those whose angina has worsened to CCS III or IV within a short period of time, or those with rest angina lasting more than 20 minutes.
  • Patients with iodine contrast agent allergy.
  • Patients with a history of coronary artery bypass grafting (CABG).
  • Target lesions related to acute myocardial infarction.
  • Target lesions involving left main stem disease.
  • Target lesions involving myocardial bridging.

Lab values

  • Patients with severe congestive heart failure (NYHA III-IV or LVEF \<30%) or acute pulmonary edema.
  • Patients with severe renal insufficiency (creatinine \>150μmol/L or estimated - -glomerular filtration rate calculated by the Cockcroft-Gault formula \<45ml/kg/1.73 m2).

Other

  • General exclusion criteria:
  • Pregnant or lactating women.
  • Patients with other comorbidities and an expected survival time of less than 1 year.
  • Patients who, for any other reason, are considered by the investigators to be unsuitable for inclusion in the study or unable to complete the study and follow-up.
    • Coronary CTA and coronary angiography exclusion criteria:
  • Patients with a body mass index \>35 when undergoing coronary CT testing, resulting in poor CT image quality due to motion artifacts, severe calcification, or inadequate iodine contrast agent filling.
  • Target lesions involving in-stent restenosis.
  • Low-quality angiography due to poor visualization of vascular boundaries or poor iodine contrast agent filling.
  • Excessive overlap of the stenotic segment or severe tortuosity of the target vessel, making QFR calculation impossible.
    • Regen

Who the study is looking for

  • Age ≥18 years
  • with stable chest pain who underwent CCTA and have at least 1 lesion with a percent diameter stenosis (DS%) between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment.These patients plan to undergo further non-invasive or invasive diagnosis and treatment.
  • Able to undergo invasive coronary angiography (ICA)
  • Capable of complying with the study procedures and fully understand the informed consent form approved by the ethics committee, and provide voluntary consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Zhongshan Hospital,Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.