Aortic Calcification and Central Blood Pressure in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- The difference between directly measured and estimated aortic (central) diastolic blood pressure and the corresponding brachial diastolic blood pressure.
研究概览
简要总结
Aim and background:
This study will seek to identify physiological and biochemical factors explaining and predicting a higher than expected central (aortic) blood pressure (BP) in patients with chronic kidney disease (CKD). The basic hypothesis of the study is that the degree of aortic calcification is an important component of elevated central BP, which, in turn, is important for the organ-damage and increased risk of cardiovascular disease associated with CKD.
Methods:
Adult patients with varying degrees of CKD undergoing scheduled coronary angiography (CAG) at Aarhus University Hospital will be included in this study.
During the CAG procedure, systolic and diastolic BP is determined in the ascending part of aorta by a calibrated pressure transducer connected to the fluid-filled CAG catheter.
Simultaneous with the registration of invasive aortic BP, estimation of central BP is performed using radial artery tonometry (SphygmoCor®), while a corresponding brachial BP is also measured.
Prior to the CAG, a non-contrast CT scan of aorta in its entirety will be performed to enable blinded quantification of calcification in the wall of aorta and coronary arteries.
Furthermore, echocardiography, resting BP measurement and a range of blood- and urine samples will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Patient referred for planned CAG at the Department of Cardiology, Aarhus University Hospital (AUH)
- •eGFR constantly either >60 ml/min or <60 ml/min in at least 2 separate blood-sample measurements over at least 3 months.
- •Signed informed consent-form.
排除标准
- •Antihypertensive treatment changed within the last two weeks prior to the CAG.
- •Severe aortic valve stenosis (<1 cm) as central hemodynamics may be altered
- •Maximum number of patients in CKD-group already reached.
- •Atrial fibrillation or other cardiac arrhythmia making radial Pulse Wave Analysis (PWA) estimations impossible.
- •Known significant stenosis of a. subclavia or a. brachialis
- •Bilateral arteriovenous-fistula (even if one or both of these have been surgically removed) as this may significantly affect the pulse-wave form.
结局指标
主要结局
The difference between directly measured and estimated aortic (central) diastolic blood pressure and the corresponding brachial diastolic blood pressure.
时间窗: During the CAG procedure
Diastolic arterial pressure will be determined in the ascending part of aorta using a calibrated pressure transducer connected to the CAG catheter. Simultaneous measurement with af Oscillometric BP-device (Microlife A2 Basic) will be conducted. The difference in mmHg will be calculated.
The degree of aortic calcification
时间窗: CT-scan will be performed prior to CAG if logistically possible and no later than 3 weeks after CAG. All Agatston scoring will be completed when all patients have been included in the study during the summer of 2021.
The degree of calcification in the wall of the ascending, arcus, descending and abdominal aorta will be measured with a non-contrast CT scan. Agatston-scoring will be applied on the CT images 2 cm after the aortic valve to the aortic bifurcation to ensure that aortic valve calcification is not included in the score. All Agatston scoring will be performed by a radiologist blinded to information on patient biochemical characteristics.
The difference between directly measured and estimated aortic (central) systolic blood pressure and the corresponding brachial systolic blood pressure
时间窗: During the CAG-procedure
Systolic arterial pressure will be determined in the ascending part of aorta using a calibrated pressure transducer connected to the CAG catheter. Simultaneous measurement with af Oscillometric BP-device (Microlife A2 Basic) will be conducted. The difference in mmHg will be calculated.
次要结局
- Association between sRANKL (soluble receptor activator of nuclear factor kappa-B ligand) and aortic calcification(Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021)
- Association between aortic calcification and LVDd (Left ventricular diameter in diastole) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and Aorta (sinus) diameter as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and PW (Posterior wall thickness) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and LAV (Left atrial volume) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and Tricuspid annular plane systolic excursion (TAPSE) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between 25-OH-Vitamin D(D3+D2) and aortic calcification(Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021)
- Association between Sclerostin and aortic calcification(Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021)
- Association between Matrix Gla Protein (MGP) and aortic calcification(Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021)
- Association between Calcification propensity score (T50test) and aortic calcification(Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021)
- Association between Fetuin-A(alfa-2-Heremans Schmid glycoprotein; AHSG) and aortic calcification(Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021.)
- Association between TRAP5B (tartrate-resistant acid phosphatase 5b) and aortic calcification(Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021)
- Association between osteoprotegerin and aortic calcification(Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021)
- Association between BsAP (bone-specific alkaline phosphatase) and aortic calcification(Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021)
- Association between P1NP (procollagen type 1 N propeptide) and aortic calcification(Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021)
- Association between aortic calcification and IVS (Interventricular septum thickness) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and Early mitral inflow velocity (E) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and Duration of Pulmonal Vein Reversal as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and Late mitral inflow velocity (A) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and Early diastolic mitral annulus velocity (E') as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and Aorta (ascendens) diameter as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and RVDd (Right ventricular diameter in diastole) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and Left Ventricular Global Longitudinal Strain (GLS) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and Two-dimensional automated evaluation of ejection fraction (2-D auto-EF) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and LAD (Left atrial diameter) as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association between aortic calcification and TEI-Index as determined during echocardiography.(No later than 1 month after central BP measurements)
- Association of arterial stiffness (defined as Pulse Wave Velocity (PWV)) and aortic calcification(No later than 1 month after Central BP.)
研究者
Jakob Tobias Nyvad
M.D., PhD-student
Central Jutland Regional Hospital