NCT01153776

Brief Summary

The purpose of this study is to find a non-invasive alternative (with using ECG gated 64-slice CT angiography) to invasive coronary angiography for detecting coronary lesions in patients who had undergone arterial switch operation for transposition of the great arteries

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

June 29, 2010

Last Update Submit

June 27, 2017

Conditions

CT Coronary AngiographyArterial Switch Operation

Keywords

Arterial switch operationTransposition of the great arteriesCongenital heart diseasesCT coronary angiography

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of 64-slice CT angiography for the detection of lesions at the ostia and proximal segments of the reimplanted coronary arteries

    Sensitivity and specificity of 64-slice CT angiography for the detection of lesions at the ostia and proximal segments of the reimplanted coronary arteries Expected sensitivity \> 95% Expected specificity \> 95%

    30 MINUTES

Study Arms (1)

64-slice CT angiography

EXPERIMENTAL

64-slice CT angiography

Procedure: 64-slice CT angiography

Interventions

64-slice CT angiographyPROCEDURE

the sensitivity and specificity of 64-slice CT angiography for the detection of lesions at the ostia and proximal segments of the reimplanted coronary arteries

64-slice CT angiography

Eligibility Criteria

Age4 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients, age 4 to 30 years old, who had undergone arterial switch operation for transposition of the great arteries, are eligible.

You may not qualify if:

  • No consent
  • Allergy to contrast agent (iodine contrast)
  • Severe renal failure (clearance \< 80ml/min/1.73m²)
  • Severe arrhythmias
  • Absence of medical care insurance
  • Pregnancy
  • Contre-indication to beta-blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Transposition of Great VesselsHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ou Phalla, MCU Ph

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2010

First Posted

June 30, 2010

Study Start

September 1, 2008

Primary Completion

March 1, 2010

Study Completion

October 1, 2011

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

FR(1)