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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02636062
• Other study ID #: C.2016.055
• Status: Withdrawn
• First received: December 10, 2015
• Last updated: April 16, 2018
• Start date: July 2017
• Est. completion date: July 2020

Study information

• Verified date: April 2018
• Source: San Antonio Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Endothelial Dysfunction
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
San Antonio Military Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with CAC > 0	Incident development of any CAC (CAC > 0) between initial scan > 5 years previous and re-scan	5 years
Secondary	Major adverse cardiovascular events	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.	5 years
Secondary	Per vessel incident CAC	Individual CAC score for each major epicardial coronary vessel in patients with development of incident CAC > 0	5 years
Secondary	Number of patients on statin therapy with incident CAC > 0 compared with statin naïve patients		5 years