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Completed

NCT Number: NCT01153776

CT Coronary Angiography After Arterial Switch Operation

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

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Key information

Age range

4 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

Objectives To find a non-invasive alternative (with using ECG-gated 64-slice CT angiography) to invasive coronary angiography for detecting coronary lesions in children who had undergone arterial switch operation for transposition of the great arteries.

Background Assessment of the integrity of reimplanted coronary arteries is crucial for long-term outcome after arterial switch operation for transposition of the great arteries. Non-invasive tests have limited accuracy for detecting coronary lesions, and invasive coronary angiography is usually required in this setting.

Materials and methods Patients (age 4 to 30 years old) who undergone arterial switch operation in neonate period are potentially eligible. They will be prospectively included in the study. They will have both examinations, their routine invasive coronary angiography and ECG-gated 64-slice CT angiography. The ability of CT to detect lesions of the ostia and proximal segments of the reimplanted coronary arteries was analyzed by blinded comparison to invasive coronary angiogram.

Expected results and clinical implications We expect to demonstrate that ECG-gated 64-slice CT angiography is safe and accurate for the detection of coronary lesions with a high sensitivity (expected sensitivity>95%) as compared to invasive angiography. In that condition, ECG-gated 64-slice CT angiography could replace the invasive coronary angiography for the follow-up of patients with reimplanted coronary arteries after arterial switch operation for transposition of the great arteries.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

64-slice CT angiography

Procedure

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

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

    Time frame: 30 MINUTES

    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%

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

CT Coronary Angiography for the Detection of Reimplanted Coronary Lesions in Patients Who Had Undergone Arterial Switch Operation for Transposition of the Great Arteries

Acronym: SCANTGV

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jun 30, 2010
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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