Ignite Creation Date:
2024-05-06 @ 7:57 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02636062
Status:
WITHDRAWN
Last Update Posted:
2018-04-18
First Post:
2015-12-10
Brief Title:
Predictors of Coronary Artery Calcium Progression in Adults With a Prior Zero Coronary Artery Calcium Score
Sponsor:
San Antonio Military Medical Center
Organization:
San Antonio Military Medical Center
Study Overview
Official Title:
Predictors of Coronary Artery Calcium Progression in Adults With a Prior Zero Coronary Artery Calcium Score
Status:
WITHDRAWN
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI - lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None