Cyanotic Heart Disease and Thrombosis
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|ClinicalTrials.gov Identifier: NCT02716402|
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Thrombosis||Radiation: Cerebral MRI and V/Q SPECT/CT||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cyanotic Congenital Heart Disease: Prevalence of Pulmonary and Cerebral Thrombi-embolic Events|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||November 2017|
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
Radiation: Cerebral MRI and V/Q SPECT/CT
Cerebral MRI and V/Q SPECT/CT
- 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
- The total numbers of white matter hyper intensity lessons (WMHL) [ Time Frame: Through study completion, an average of 1 year ]The numbers of WMHL will be compared with previous scans.
- The size of the white matter hyper intensity lessons (WMHL) [ Time Frame: Through study completion, an average of 1 year ]The size of the WMHL will be compared with previous scans.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716402
|Department of Cardiology, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Annette S Jensen, MD, PhD||Rigshospitalet, Denmark|