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临床试验/NCT02636062
NCT02636062撤回不适用

Predictors of Coronary Artery Calcium Progression in Adults With a Prior Zero Coronary Artery Calcium Score

San Antonio Military Medical Center0 个研究点开始时间: 2017年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Number of patients with CAC > 0

研究概览

简要总结

This study is a non-randomized prospective cohort study that will define the rate of index atherosclerotic plaque development in adults with a prior coronary artery calcium (CAC) score of 0 given prior CAC zero > 5 years previous. Ancillary testing of serum, whole blood, and endothelial dysfunction will be performed to investigate any detectable systemic processes that predict CAC development.

详细描述

This study is a non-randomized prospective cohort study that will define the rate of index atherosclerotic plaque development in adults with a prior CAC score of 0 given prior CAC zero > 5 years previous. Study personnel will abstract CAC and coronary computed tomography angiography (CCTA) results on or prior to 31 December 2010 in a single, high-volume military medical center. All patients with CAC scores of zero, irrespective of whether or not this zero CAC was calculated in the presence of a CCTA with non-calcified plaque, will be offered inclusion in the study cohort. Patients will be contacted via telephone and offered study participation. Patients who sign written informed consent will be interviewed to abstract current medical history, medications, exercise practices, and social history. Cardiovascular risk factors of interest will be hypertension, hyperlipidemia, diabetes mellitus, and family history. Patients will then undergo blood draw (complete metabolic panel, complete blood count, lipid panel, serum insulin, high-sensitivity C-reactive protein (CRP), hemoglobin A1c, and thyroid function testing) to screen for undergoing cardiovascular risk factors and to be used as potential risk markers. Additionally, whole blood and serum will be obtained for future investigation to determine new markers of coronary artery disease (CAD) progression and genetic polymorphisms that may predict CAD progression. Patients will also undergo EndoPat testing utilizing an EndoPAT 2000® (digital pulse amplitude tonometry) to assess for endothelial dysfunction. Finally, patients will undergo repeat coronary artery calcium scoring based on standard laboratory protocols based on heart rate and body mass index.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older
  • Coronary Artery Calcium scoring test graded as 0 Agatston units

排除标准

  • Interval development of symptomatic coronary artery disease (defined as prior PCI, CABG, or myocardial infarction) in the time between initial CAC scan and current data review. (These patients will not be enrolled in the trial to undergo repeat CAC testing, but any major cardiovascular events (MACE) will be documented in order to report the 5 year MACE rates amongst CAC zero patients in our population.)
  • Pregnant females
  • Implantable cardiac pacemaker or defibrillator
  • Prior cardiac surgery for valvular heart disease
  • Patients with CAC scores ≥ 1
  • Patients in atrial fibrillation at the time of CAC acquisition

结局指标

主要结局

Number of patients with CAC > 0

时间窗: 5 years

Incident development of any CAC (CAC \> 0) between initial scan \> 5 years previous and re-scan

次要结局

  • Major adverse cardiovascular events(5 years)
  • Per vessel incident CAC(5 years)
  • Number of patients on statin therapy with incident CAC > 0 compared with statin naïve patients(5 years)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Dustin M. Thomas

Director, Cardiac CT Imaging and Cardiovascular Research

San Antonio Military Medical Center

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