Computed Tomographic Angiography or Conventional Coronary... | NCT00566059

Studies
Computed Tomographic Angiography or Conventional Coronary Angiography in Clinical Decision Making

NCT00566059

Sponsor

University Medical Center Groningen

Status

Completed

Last Update Posted

Dec 3, 2007Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Coronary Artery Disease
Coronary Artery Stenosis

Interventions

Not provided

Countries

Netherlands

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 2007

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 2006

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Nov 30, 2007

First Submission Date that Met QC Criteria

Nov 30, 2007

First Posted Date

Dec 3, 2007Estimated

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 30, 2007

Last Update Posted Date

Dec 3, 2007Estimated

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

Patients planned for elective conventional coronary angiography will undergo CT coronary angiography (Dual Source CT) in order to assess the correlation of stenosis detection and therapeutic advice between conventional and CT coronary angiography. We hypothesize that their is a good correlation between conventional and CT coronary angiography for stenosis detection and therapeutic advice.

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

Not provided

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

60Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 50 years of age
Scheduled for elective coronary angiography

Exclusion Criteria:

Patients with known iodine allergy
Severe renal insufficiency (creatinine levels > 120 micromol/L)
Hyperthyroidism
Cardiac arrhythmias
Unstable clinical condition
Inability to follow breath-hold commands
Previous PCI or CABG were excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients over 50 years of age, scheduled for elective coronary angiography

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felix Zijlstra, MD PhD	University Medical Center Groningen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen		Groningen			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D023921	Coronary Stenosis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided