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Cyanotic Heart Disease and Thrombosis

Primary Purpose

Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cerebral MRI and V/Q SPECT/CT
Sponsored by
Annette Schophuus Jensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thrombosis focused on measuring Cyanotic congenital heart disease, pulmonary thrombosis, cerebral thrombosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Cardiology, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cyanotic congenital heart disease

Arm Description

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

Outcomes

Primary Outcome Measures

Pulmonary and cerebral thrombosis
Numbers and locations of cerebral and and pulmonary thrombosis, which will be compared with previous examinations

Secondary Outcome Measures

The total numbers of white matter hyper intensity lessons (WMHL)
The numbers of WMHL will be compared with previous scans.
The size of the white matter hyper intensity lessons (WMHL)
The size of the WMHL will be compared with previous scans.

Full Information

First Posted
March 8, 2016
Last Updated
August 27, 2018
Sponsor
Annette Schophuus Jensen
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1. Study Identification

Unique Protocol Identification Number
NCT02716402
Brief Title
Cyanotic Heart Disease and Thrombosis
Official Title
Cyanotic Congenital Heart Disease: Prevalence of Pulmonary and Cerebral Thrombi-embolic Events
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Annette Schophuus Jensen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
Cyanotic congenital heart disease, pulmonary thrombosis, cerebral thrombosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyanotic congenital heart disease
Arm Type
Other
Arm Description
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 Type
Radiation
Intervention Name(s)
Cerebral MRI and V/Q SPECT/CT
Intervention Description
Cerebral MRI and V/Q SPECT/CT
Primary Outcome Measure Information:
Title
Pulmonary and cerebral thrombosis
Description
Numbers and locations of cerebral and and pulmonary thrombosis, which will be compared with previous examinations
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
The total numbers of white matter hyper intensity lessons (WMHL)
Description
The numbers of WMHL will be compared with previous scans.
Time Frame
Through study completion, an average of 1 year
Title
The size of the white matter hyper intensity lessons (WMHL)
Description
The size of the WMHL will be compared with previous scans.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette S Jensen, MD, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cyanotic Heart Disease and Thrombosis

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