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

Withdrawn

• Conditions: Atherosclerosis; Coronary Artery Disease; Endothelial Dysfunction

• Registration Number: NCT02636062
• Lead Sponsor: San Antonio Military Medical Center

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.

Study Timeline

• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-21
• Study Start: 2017-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18
• Primary Completion: 2019-12
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with CAC > 0	5 years	Incident development of any CAC (CAC \> 0) between initial scan \> 5 years previous and re-scan

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	5 years	The incidence of major adverse cardiovascular events (defined as death from cardiac cause, myocardial infarction, revascularization of obstructive coronary artery disease, stroke, heart failure, and new onset of atrial fibrillation), in all subjects screened for the study between initial CAC scan demonstrating zero CAC and current study screening.
Per vessel incident CAC	5 years	Individual CAC score for each major epicardial coronary vessel in patients with development of incident CAC \> 0
Number of patients on statin therapy with incident CAC > 0 compared with statin naïve patients	5 years