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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-derived FFR guided-ITS group | Experimental | CT-derived FFR≤0.8; ITS plus OMT |
|
| Medical therapy group | Active Comparator | CT-derived FFR≤0.8; OMT alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITS plus OMT | Other | Invasive treatment strategy plus optimal medical therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) | A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Death | All-cause death and cardiac death. | 1 year |
| MI | Target vessel related and non-target vessel related MI. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian'an Wang, MD | Contact | +(86)(571) 87784808 | wangjianan111@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian'an Wang, MD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OMT | Other | Optimal medical therapy alone |
|
| Revascularization | Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization. | 1 year |
| Stroke | Stroke (ischemic and hemorrhagic). | 1 year |
| Cost-effectiveness analysis | Medical expenses of treatment and follow-up. | 1 year |
| Quality of life assessed by Seattle Angina Questionnaire | Frequency of angina and the disease-specific quality of life, as assessed by Seattle Angina Questionnaire. | 1 year |
| MACE | A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization. | 1 month, 2 years, 3 years, 5 years |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |