Coronary Anomalies in Congenital Heart Disease | NCT01278771

Studies
Coronary Anomalies in Congenital Heart Disease

NCT01278771

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Jan 20, 2011Estimated

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Congenital Heart 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

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 16, 2011

First Submission Date that Met QC Criteria

Jan 18, 2011

First Posted Date

Jan 19, 2011Estimated

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

Jan 19, 2011

Last Update Posted Date

Jan 20, 2011Estimated

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

This is a retrospective study. The investigators shall review the angiography data of 1200 consecutive cardiac catheterizations of children and babies with CHD (Congenital Heart Disease) since 1998 till now.

Coronary artery origin and course will be evaluated in relation to the morphologic cardiac anomalies.

Coronary artery anomalies will be described and statistical analysis will be performed.

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

1,200Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cradiac catheterization with angiography with congenital heart disease.

Exclusion Criteria:

no congenital heart disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

86 Years

Standard Ages

ChildAdultOlder Adult

Study Population

1200 patients with Congenital Heart Disease who underwent Cardiac catheterization with angiography.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Avraham Lorber, Prof	Rambam Medical Health Care Campus	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided