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

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ClinicalTrials.gov Identifier: NCT02636062
Recruitment Status : Withdrawn (PI - lack of funding)
First Posted : December 21, 2015
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dustin M. Thomas, San Antonio Military Medical Center

Tracking Information
First Submitted Date December 10, 2015
First Posted Date December 21, 2015
Last Update Posted Date April 18, 2018
Estimated Study Start Date July 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 16, 2015)
Number of patients with CAC > 0 [ Time Frame: 5 years ]
Incident development of any CAC (CAC > 0) between initial scan > 5 years previous and re-scan
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02636062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 16, 2015)
  • Major adverse cardiovascular events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The biological specimens collected in this study will be used for future testing and evaluation of exploratory systemic biomarkers with respect to prediction of coronary artery disease (CAD) progression and incident development of CAD. Specifically, samples are being collected to investigate pro-fibrotic and pro-inflammatory makers and the effect on CAD development and progression as measured by coronary artery calcification (CAC). DNA samples will be tested for genetic factors and identify trends amongst patients with CAC development, particularly focusing on those with aggressive, multivessel CAC development.
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.
Condition
  • Coronary Artery Disease
  • Endothelial Dysfunction
  • Atherosclerosis
Intervention Not Provided
Study Groups/Cohorts
  • Follow-up CAC > 0
    All patients with CAC scores of zero > 5 years previous will be invited to enroll and undergo repeat CAC scanning. This group will include all patients that develop incident CAC.
  • Follow-up CAC zero
    All patients with CAC scores of zero > 5 years previous will be invited to enroll and undergo repeat CAC scanning. This group will include all patients who continue to have a CAC of zero.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: April 16, 2018)
0
Original Estimated Enrollment
 (submitted: December 16, 2015)
1000
Estimated Study Completion Date July 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02636062
Other Study ID Numbers C.2016.055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dustin M. Thomas, San Antonio Military Medical Center
Study Sponsor San Antonio Military Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Dustin M Thomas, MD San Antonio Military Medical Center
PRS Account San Antonio Military Medical Center
Verification Date April 2018