Systematic Assessment of Competitive Flow in Coronary Art... | NCT01118468

Studies
Systematic Assessment of Competitive Flow in Coronary Artery Bypass Grafts by Wave Intensity Analysis

NCT01118468

Sponsor

Imperial College London

Status

Unknown status

Last Update Posted

Feb 8, 2017Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Coronary Artery Bypass

Interventions

Not provided

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

May 5, 2010

First Submission Date that Met QC Criteria

May 5, 2010

First Posted Date

May 6, 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

Feb 6, 2017

Last Update Posted Date

Feb 8, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Narrowing of the arteries that supply blood to the heart can lead to heart attacks and death. One way of treating this is to use artery and vein grafts from other parts of the body to bypass the narrowing. However, the blood flow from these grafts "competes" with flow through the natural coronary artery. This may contribute to grafts narrowing with time. This protocol aims to determine the pressure changes responsible for this effect. This could improve our understanding of why some grafts last longer than others.

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

40Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with previous coronary artery bypass grafts undergoing coronary angiography and graft restudy

Exclusion Criteria:

Patient's with cardiac pacemakers, valvular heart disease, and chronic renal failure
Unable to consent
Contraindications to adenosine
Contraindications to cardiac MRI

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

Patients with previous bypass grafts undergoing angiography/ angioplasty who meet stduy criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Justin E Davies, MRCP, PhD	Contact	020 7594 33 86		justin.davies@imperial.ac.uk
Sayan Sen, MRCP	Contact	020 7594 33 86		sayan.sen@imperial.ac.uk

Overall Officials

Name	Affiliation	Role
Justin E Davies, MRCP PhD	Imperial College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imperial College NHS Trust	Recruiting	London			United Kingdom