- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02636062
Predictors of Coronary Artery Calcium Progression in Adults With a Prior Zero Coronary Artery Calcium Score
April 16, 2018 updated by: Dustin M. Thomas, San Antonio Military Medical Center
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.
Study Overview
Status
Withdrawn
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
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
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
|
5 years
|
Number of patients on statin therapy with incident CAC > 0 compared with statin naïve patients
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dustin M Thomas, MD, San Antonio Military Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2017
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
July 1, 2020
Study Registration Dates
First Submitted
December 10, 2015
First Submitted That Met QC Criteria
December 16, 2015
First Posted (Estimate)
December 21, 2015
Study Record Updates
Last Update Posted (Actual)
April 18, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C.2016.055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
San Luigi Gonzaga HospitalRecruitingCoronary Disease | STEMI | Coronary Artery Ectasia | Right Coronary Artery Occlusion | Right Coronary Artery StenosisSpain, Italy