Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ITS plus OMT, OMT.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Myocardial Ischaemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Coronary Computed Tomography-Derived Fraction Flow Reserve (FFR)-Guided Invasive Treatment Strategy (ITS) Versus Optimal Medical Therapy (OMT) Alone in Patient With Chronic Coronary Syndrome
Overview
The overall purpose of ACCURATE II trial is to compare the clinical outcomes of CT-derived FFR guided strategy versus medical therapy in patients with chronic coronary syndrome.
Detailed description
ACCURATE II is a prospective, multicenter, randomized clinical trial comparing the clinical outcome and cost-effectiveness of the two management strategies. CT-FFR-guided invasive treatment strategy versus optimal medical therapy, in management of patients with chronic coronary syndrome. The study is powered to detect if the primary endpoint by the CT-FFR-guided strategy is superior to the medical therapy strategy.
Interventions
- Other ITS plus OMT
Invasive treatment strategy plus optimal medical therapy - Other OMT
Optimal medical therapy alone
Primary outcome measures
- Major adverse cardiac events (MACE) [Time frame: 1 year]
Secondary outcome measures (7)
- Death [Time frame: 1 year]
- MI [Time frame: 1 year]
- Revascularization [Time frame: 1 year]
- Stroke [Time frame: 1 year]
- Cost-effectiveness analysis [Time frame: 1 year]
- Quality of life assessed by Seattle Angina Questionnaire [Time frame: 1 year]
- MACE [Time frame: 1 month, 2 years, 3 years, 5 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80
- Patients with chronic coronary syndromes
- Signed written informed consent
Exclusion criteria
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled)
- Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- Sinus arrhythmia, cardiogenic shock, or severe heart failure (NYHA≥III)
- Inability or unwillingness to undergo CT scan or coronary angiography
- Patients on hemodialysis or with severe hepatic or renal insufficiency
- Left main coronary artery stenosis ≥ 50%
- Target vessel total occlusion
- Pregnancy or intention to become pregnant during the course of the trial
- Patients with a life expectancy less than 2 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
Identifiers
NCT: NCT05824520 · 2023-0318