Cyanotic Heart Disease and Thrombosis

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716402
• Other study ID #: H-15012759
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: August 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Thrombosis

Intervention

Radiation:
• Cerebral MRI and V/Q SPECT/CT
Cerebral MRI and V/Q SPECT/CT

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Annette Schophuus Jensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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