Cyanotic Congenital Heart Disease: Prevalence of Pulmonary and Cerebral Thrombi-embolic Events
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Pulmonary and cerebral thrombosis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Cyanotic congenital heart disease
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
Intervention: Cerebral MRI and V/Q SPECT/CT (Radiation)
Outcomes
Primary Outcomes
Pulmonary and cerebral thrombosis
Time Frame: Through study completion, an average of 1 year
Numbers and locations of cerebral and and pulmonary thrombosis, which will be compared with previous examinations
Secondary Outcomes
- The total numbers of white matter hyper intensity lessons (WMHL)(Through study completion, an average of 1 year)
- The size of the white matter hyper intensity lessons (WMHL)(Through study completion, an average of 1 year)
Investigators
Annette Schophuus Jensen
PhD MD
Rigshospitalet, Denmark