Detection of Subclinical Atherosclerosis in Asymptomatic... | NCT00862056

Studies
Detection of Subclinical Atherosclerosis in Asymptomatic Individuals

NCT00862056

Sponsor

Piedmont Healthcare

Status

Completed

Last Update Posted

Nov 20, 2017Actual

Enrollment

73Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Cardiac CT

Countries

United States

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009Actual

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 12, 2009

First Submission Date that Met QC Criteria

Mar 13, 2009

First Posted Date

Mar 16, 2009Estimated

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

Nov 16, 2017

Last Update Posted Date

Nov 20, 2017Actual

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

73Actual

Label	Type	Description	Intervention Names
Cardiac CT		All participants will undergo a coronary artery CT angiogram	Procedure: Cardiac CT

Name	Type	Description	Arm Group Labels	Other Names
Cardiac CT	Procedure	All participants will undergo a coronary artery CT angiogram with contrast.	Cardiac CT

Measure	Description	Time Frame
The primary endpoint of the study is identifying the prevalence of coronary artery disease (CAD) in an asymptomatic population of patients without prior history of, but with high likelihood of CAD.		6 months, 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males between ages 35-90 or females between ages 40-90
No known coronary artery disease
- no prior coronary disease by cardiac catheterization (no more than 40% in any major epicardial vessel)
- no prior myocardial infarction
- no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous leads)
- no prior non-ST-elevation myocardial infarction (CK-MB > 2x ULN or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints)
- no prior coronary revascularization procedure
Aymptomatic
- no chest pain, shortness of breath, angina or angina-equivalent that is assumed to be related to myocardial ischemia
Presence of a high-risk feature (at least one of the following four will quality)
- High FRS ≥20% (http://hp2010.nhlbihin.net/atpiii/calculator.asp)
- Diabetes Mellitus
- Premature CAD in a first-degree relative
- High Risk Lipid Profile (must meet one of the following laboratory criteria)
  1. LDL > 250 mg/dL
  2. HDL < 20 mg/dL
  3. Triglycerides > 1000 mg/dL
  4. LP(a) > 80 mg/dL
Provide written informed consent and Authorization for Use/Disclosure of PHI

Exclusion Criteria:

Known genetic form of hypercholesterolemia based on clinical criteria (e.g. familial hypercholesterolemia, etc.)
Creatinine 1.5 mg/dL or greater
Irregular rhythm precluding cardiac CT examination
Uncontrolled hypertension (SBP>210 mmHg or DBP>140 mmHg on treatment)
Known moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion)
Known Pregnancy
Unwilling or unable to consent
Presence of any co-morbidity that makes life expectancy less than 24 months
Unwilling or unable to complete follow-up
Unwilling or unable to provide written informed consent and Authorization for Use/Disclosure of PHI

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Coronary Artery Disease

Sampling Method

Non-Probability Sample

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases