320 Multidetector Computed Tomography Prior to Coronary A... | NCT01169948

Studies
320 Multidetector Computed Tomography Prior to Coronary Artery Bypass Surgery

NCT01169948

Sponsor

University of Edinburgh

Status

Withdrawn

Last Update Posted

Mar 14, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Coronary Disease

Interventions

Computed tomography scan

Countries

United Kingdom

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

Mar 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not funded.

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 14, 2010

First Submission Date that Met QC Criteria

Jul 23, 2010

First Posted Date

Jul 26, 2010Estimated

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

Mar 13, 2013

Last Update Posted Date

Mar 14, 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

Recent advances in technology have resulted in the development of scanners that can n image the heart arteries within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. This means that coronary heart disease may be more readily identified (or ruled out) and allow better diagnosis and treatment of patients with symptoms suggesting coronary heart disease. Here, we propose to assess the latest and most powerful scanners to see if it can accurately diagnose the extent of coronary artery disease and facilitate the planning of heart surgery.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients awaiting cardiac surgery			Radiation: Computed tomography scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computed tomography scan	Radiation	Computed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and myocardial perfusion scanning.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coronary artery stenosis defined qualitatively by trained observers and quantitatively by computer software		1 month

Secondary Outcomes

Measure	Description	Time Frame
Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who have undergone conventional coronary angiography and have been referred for coronary artery bypass surgery or valve replacement

Exclusion Criteria:

age less than 18
pregnancy or breast feeding
inability to undergo computed tomography scanning
inability to give informed consent
severe renal failure (serum creatinine >250umol/l or estimated glomerular filtration rate <15ml/min)
known allergy to iodinated contrast

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Outpatients awaiting cardiac surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David E Newby, PhD BM DM	University of Edinburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Infirmary of Edinburgh		Edinburgh	Scotland	EH16 4SA	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided