2024-518706-41-01招募中3 期
Prognostic Performance of Quantitative Myocardial Perfusion Imaging Using H2[15O] Positron Emission Tomography in Coronary Artery Disease - The AQUA COR trial
Vaestra Goetalandsregionen1 个研究点 分布在 1 个国家目标入组 40,000 人开始时间: 2026年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40,000
- 试验地点
- 1
- 主要终点
- The primary endpoint of the main basket cohort is the time to first occurrence of MACE-1, defined as a composite of all-cause death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.
研究概览
简要总结
The primary objective for the main basket cohort is to determine prognostic thresholds for predicting major adverse cardiovascular events-1 (MACE) in participants with clinically suspected or known CAD, using quantitative H2[15O] PET-derived absolute global and regional MBF at rest and during pharmacological stress (ml/min/g), as well as MFR, to discriminate between high- and low-risk individuals.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed written consent.
- •Female and male subjects ≥ 18 years.
- •Clinically suspected or known CAD.
- •Clinical indication for MPI in alignment with current evidence-based practice, clinical guidelines, and/or local routines (applies to both the main basket cohort and the additional basket cohorts A - D and F - H).
- •In case of the additional basket cohorts, subjects must meet one of the following additional criteria: A) Antianginal treatment basket cohort High pretest probability of CAD, angina pectoris as the primary symptom, no or recently initiated or inadequate antianginal treatment that can be withheld for a duration equivalent to 3 - 5 drug half-lives, and no prior history of coronary intervention. B) Heart failure treatment basket cohort Newly diagnosed idiopathic dilated cardiomyopathy and no or recently initiated heart failure therapy. C) TAVI basket cohort Severe aortic stenosis accepted for TAVI. D) CTO basket cohort Coronary CTO eligible for 1) optimized medical treatment alone, 2) PCI, or 3) reducer stent implantation. E) Anti-inflammatory treatment basket cohort Cardiac sarcoidosis with an indication for anti-inflammatory treatment. F) CKD basket cohort CKD of varying severity, defined as eGFR < 60 ml/min/1.73 m2, not receiving maintenance dialysis at baseline. G) Long-term dialysis basket cohort Maintenance dialysis in end-stage CKD. H) Kidney transplantation basket cohort End-stage CKD under evaluation for kidney transplantation. I) Takotsubo syndrome basket cohort Classic, hemodynamically stable acute Takotsubo syndrome. J) STEMI basket cohort Recently revascularized acute STEMI.
排除标准
- •Contraindications for the used pharmacological stress agents.
- •Contraindications for PET/CT or PET/MR, such as severe claustrophobia or non-MR-conditional implants.
- •Inability to understand and adhere to all study-related procedures, including participant preparation.
- •Pregnancy or lactation. All female participants of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or inconclusive, a serum pregnancy test will be required. For any serial H2[15O] PET studies, this procedure has to be performed before every single scan.
结局指标
主要结局
The primary endpoint of the main basket cohort is the time to first occurrence of MACE-1, defined as a composite of all-cause death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.
The primary endpoint of the main basket cohort is the time to first occurrence of MACE-1, defined as a composite of all-cause death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.
次要结局
- Time to first occurrence of MACE-1 in the main basket cohort, defined as a composite of all-cause death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.
- Time to first occurrence of MACE-2 in the main basket cohort, defined as a composite of cardiovascular death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.
- Time to first occurrence of individual cardiovascular and non-cardiovascular events in the main basket cohort during a follow-up period of up to 10 years. These events include the individual components of MACE-1 and -2, hospitalization for unstable angina, hospitalization for heart failure, and unplanned ischemia-driven revascularization (PCI/CABG), with a 90-day blanking period applied to revascularization events. For risk-prediction analyses, 2- and 5-year time horizons will be applied.
研究者
Christian Polte
Scientific
Vaestra Goetalandsregionen
研究点 (1)
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