Clinical trial NCT02636062: Predictors of Coronary Artery Calcium Progression in Adults With a Prior Zero Coronary Artery Calcium Score
Official title: Predictors of Coronary Artery Calcium Progression in Adults With a Prior Zero Coronary Artery Calcium Score
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Endothelial Dysfunction
Atherosclerosis
Keywords: Coronary disease
Coronary artery disease (CAD)
Endothelial dysfunction
Coronary artery calcium (CAC)
Lead sponsor: San Antonio Military Medical Center
Sponsor class: FED
First posted: 2015-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (\> 18 years old) with a prior CAC score of 0 \> 5 years ago or more will be contacted to enroll and undergo repeat CAC scanning.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of patients with CAC > 0
timeFrame: 5 years
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 5 years
measure: Per vessel incident CAC
timeFrame: 5 years
measure: Number of patients on statin therapy with incident CAC > 0 compared with statin naïve patients
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: San Antonio Military Medical Center
name: Dustin M Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: