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Cyanotic Heart Disease and Thrombosis

Cyanotic Congenital Heart Disease: Prevalence of Pulmonary and Cerebral Thrombi-embolic Events

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02716402
Enrollment
50
Registered
2016-03-23
Start date
2015-11-30
Completion date
2017-11-30
Last updated
2018-08-29

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

Conditions

Thrombosis

Keywords

Cyanotic congenital heart disease, pulmonary thrombosis, cerebral thrombosis

Brief summary

The purpose of the study is to examine previously examined patients with cyanotic congenital heart disease to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.

Detailed description

Patients with cyanotic congenital heart disease have reduced oxygen content in their blood due to abnormal connection between the heart's right and left sides. The reduced oxygenation of the blood affects several organs of the body and a common complications to the disease is blood clots. Despite the patients are young and do not have typical risk factors, previous studies have shown, that they have a very high prevalence of thrombosis in the lungs and brain. The reason for the increased prevalence of blood clots is not known. A previous study investigated the prevalence of blood clots systematically in patients with cyanotic congenital heart disease and found that approximately 30-40% of the patients had had a clot in the lung or brain. Thus, the study could not predict, when the patient had had a thrombotic event, and most of the patients did not previously had imaging performed. Therefore the aim of this study is to re-examine previously examined cyanotic patients regardless of previous medical history, to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.

Interventions

RADIATIONCerebral MRI and V/Q SPECT/CT

Cerebral MRI and V/Q SPECT/CT

Sponsors

Annette Schophuus Jensen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients with cyanotic congenital heart disease who have previously participated in the study 'cyanotic congenital heart disease: Hemostatic abnormalities and clinical manifestations' (H-KF-2006-4068). * Clinically stable

Exclusion criteria

* Patients who are not guardians for themselves (not adult). * Age \<18 years.

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary and cerebral thrombosisThrough study completion, an average of 1 yearNumbers and locations of cerebral and and pulmonary thrombosis, which will be compared with previous examinations

Secondary

MeasureTime frameDescription
The total numbers of white matter hyper intensity lessons (WMHL)Through study completion, an average of 1 yearThe numbers of WMHL will be compared with previous scans.
The size of the white matter hyper intensity lessons (WMHL)Through study completion, an average of 1 yearThe size of the WMHL will be compared with previous scans.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026