Knowledge-based Iterative Model Reconstruction at Low-kil... | NCT01896674

Studies
Knowledge-based Iterative Model Reconstruction at Low-kilovoltage (kV) Cardiac Computed Tomography (CT)

NCT01896674

Sponsor

Kumamoto University

Status

Completed

Last Update Posted

Jul 11, 2013Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Coronary Artery Disease

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

Jul 2013

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

May 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Not provided

First Submitted Date

Jul 8, 2013

First Submission Date that Met QC Criteria

Jul 10, 2013

First Posted Date

Jul 11, 2013Estimated

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

Jul 10, 2013

Last Update Posted Date

Jul 11, 2013Estimated

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

The purpose of this study was to compare FBP-, hybrid IR-, and IMR techniques to assess their role in the identification of coronary artery disease and abnormalities in cardiac structures.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

21Actual

Measure	Description	Time Frame
Contrast to noise ratio of coronary arteries		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A BMI of 27 kg/m2 or less and a coronary calcium score of less than 1,000 Agatston units.

Exclusion Criteria:

BMI exceeded 27 kg/m2
renal dysfunction (serum creatinine level > 1.5 mg/dl)
atrial fibrillation
prior coronary artery bypass grafting
heart failure (New York Heart Association class III-IV)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

We enroll consecutive patients.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24661824	Derived	Yuki H, Utsunomiya D, Funama Y, Tokuyasu S, Namimoto T, Hirai T, Itatani R, Katahira K, Oshima S, Yamashita Y. Value of knowledge-based iterative model reconstruction in low-kV 256-slice coronary CT angiography. J Cardiovasc Comput Tomogr. 2014 Mar-Apr;8(2):115-23. doi: 10.1016/j.jcct.2013.12.010. Epub 2014 Jan 12.

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