Cyanotic Heart Disease and Thrombosis

August 27, 2018 updated by: Annette Schophuus Jensen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Cardiology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Through study completion, an average of 1 year
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)
Time Frame: Through study completion, an average of 1 year
The size of the WMHL will be compared with previous scans.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Annette Schophuus Jensen

Investigators

  • Principal Investigator: Annette S Jensen, MD, PhD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15012759

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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