Cyanotic Heart Disease and Thrombosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thrombosis

Intervention / Treatment
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* Radiation: Cerebral MRI and V/Q SPECT/CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cyanotic congenital heart disease<br>Patients who previously have been examined with cerebral MRI and V/Q SPECT/CT will be re-examined with cerebral MRI and V/Q SPECT/CT | Radiation: Cerebral MRI and V/Q SPECT/CT<br>* Cerebral MRI and V/Q SPECT/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary and cerebral thrombosis | Numbers and locations of cerebral and and pulmonary thrombosis, which will be compared with previous examinations | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total numbers of white matter hyper intensity lessons (WMHL) | The numbers of WMHL will be compared with previous scans. | Through study completion, an average of 1 year | 
| The size of the white matter hyper intensity lessons (WMHL) | The size of the WMHL will be compared with previous scans. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyanotic congenital heart disease, pulmonary thrombosis, cerebral thrombosis