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

NCT02636062 | Withdrawn

• 1 other identifier: C.2016.055
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Endothelial Dysfunction; Atherosclerosis

Keywords

Coronary disease; Coronary artery disease (CAD); Endothelial dysfunction; Coronary artery calcium (CAC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Antonio Military Medical Center: lead

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Dustin M Thomas, MD

  San Antonio Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac CT Imaging and Cardiovascular Research

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 21, 2015
• Study Start: July 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share