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Идёт набор NCT06979427

CTFFR and Prediction of Non-Significant CAD Lesions

Без фазы С лечением Chronic Coronary Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: NIFFR.
Кому может быть актуально
Состояния в реестре: Chronic Coronary Syndrome. Базовые параметры: 20 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Иран
Следующий шаг
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Официальное название

Evaluation of the Ability of CTFFR to Determine Non-significant Lesions of Coronary Disease Based on MACE in One-year Follow-up of Patients (Seeing Beyond the Stenosis: CTFFR and MACE in a One-Year Follow-Up)

Обзор

In this prospective cohort study, 250 patients with suspected or known CAD and at least one intermediate coronary lesion (50-70% stenosis) who had a NiFFR value greater than 0.80 underwent coronary computed tomography angiography (CCTA) with NiFFR assessment. Patients were followed for one year to monitor for MACE

Подробное описание

This prospective cohort includes people with known or suspected CAD who had both CCTA and ICA with this index (FFR) measurements. Patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on CCTA and then underwent FFR testing.

Data about the patients was acquired from the Professor Kojuri registry. The database provided demographic information for instance age, gender, CAD family history, prior CAD history, hypertension (HTN), diabetes mellitus (DM), and hyperlipidaemia (HLP). The prevalence of cigarette smoking and the ejection fraction of the left ventricle. Lesion and Vessel Characteristics were also collected from registry.

The target vessel was identified (LAD, RCA, LCX, or LMC), the lesion was located (proximal, mid, or bifurcation), the vessel diameters were measured (proximal, distal, stenotic), and the lesion length was determined. Measurements were taken using CCTA datasets using semi-automated software methods.

Patients were clinically monitored for one year after examination. The primary outcome was the occurrence of major cardiovascular consequences, or MACE, which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons. Throughout the one-year study period, all participants were visited every three months and followed up with phone calls.

Вмешательства

  • Диагностический тест NIFFR
    Fractional flow reserve derived from CT angiography from lesion between 50-70%

Первичные конечные точки

  • Number of patients with MACE [Срок оценки: 1 year]
  • Number of patients with bleeding [Срок оценки: 1 year]
Вторичные конечные точки (1)
  • Number of patients with dyspnoea [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on CCTA and then underwent FFR testing

Критерии исключения

  • Patients having past coronary artery bypass graft surgery (CABG)
  • previous PCI in the target vascular
  • significant renal impairment define with eGFR < 30 mL/min/1.73 m²
  • contrast allergy
  • poor image quality that prevented appropriate CCTA or CT-FFR analysis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Диагностика

Центры проведения

Иран · 1 центр
  • Professor Kojuri Cardiology Clinic — Shiraz

Публикации

  • Khalafinezhad H, Zarifkar H, Vafa RG, Zarifkar H, Mirrhosseini A, Kojuri J. Evaluation of the ability of CTFFR to determine non-significant lesions of coronary disease based on MACE in one-year follow-up of patients (seeing beyond the stenosis: CTFFR and MACE in a one-year follow-up). BMC Cardiovasc Disord. 2026 Mar 26;26(1):393. doi: 10.1186/s12872-026-05782-0. PMID 41888687

Идентификаторы

NCT: NCT06979427 · 1403.414

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗