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Thirty years arterial switch operation for transposition of the great arteries; a follow-up study.

Thirty years arterial switch operation for transposition of the great arteries; a follow-up study. - TGA - 30

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39105
Enrollment
80
Registered
2010-12-20
Start date
2011-08-11
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventriculo-arterial discordance

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

Inclusion criteria: transposition of the great arteries arterial switch operation in WKZ 12 years of age or older wiritten informed consent

Exclusion criteria

Exclusion criteria: For MRI: pacemaker, claustrophobia, decreased renal function (the latter only for use of Gadolinium late enhancement)

Design outcomes

Secondary

MeasureTime frame
The predictive value of several serum markers to assess poor left ventricular function in patients after ASO will be evaluated, with echocardiography and Magnetic Resonance Imaging (MRI) as reference. The predictive value of serum endothelial damage markers to determine presence of atherosclerosis will be assessed with Carotid Intima-Media Thickness (CIMT) and Computed Tomography (CT) scan as reference. Also, the serum endothelial markers will be correlated to endothelial dysfunction as established by flow mediated dilation (FMD).

Primary

MeasureTime frame
For the 1st objective, endpoints will be occurrence of an adverse outcome (e.g. late mortility, reoperation, diminished LV function, arrhythmia, signs of myocardial ischemia) and the operation related factors that are independently associated with these outcomes. For the 2nd objective, the extent and incidence of wall irregularities in the coronary arteries and the calcium score will be determined in ASO patients. To gain more insight in the pathophysiology behind this, both details of the anatomy of the coronary arteries, endothelial function and the presence of endothelial and immunological markers will be investigated.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)