Predictors of Coronary Artery Calcium Progression in Adul... | NCT02636062

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

NCT02636062

Sponsor

San Antonio Military Medical Center

Status

Withdrawn

Last Update Posted

Apr 18, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Coronary Artery Disease
Endothelial Dysfunction
Atherosclerosis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI - lack of funding

Expanded Access Info

Start Date

Jul 2017Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

Dec 10, 2015

First Submission Date that Met QC Criteria

Dec 16, 2015

First Posted Date

Dec 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2018

Last Update Posted Date

Apr 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dustin M. Thomas, Director, Cardiac CT Imaging and Cardiovascular Research, San Antonio Military Medical CenterPrincipal Investigator

Lead Sponsor

San Antonio Military Medical CenterFED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dustin M Thomas, MD	San Antonio Military Medical Center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D050197	Atherosclerosis
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided

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.