Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cyanotic Heart Disease and Thrombosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716402
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Annette Schophuus Jensen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Thrombosis Radiation: Cerebral MRI and V/Q SPECT/CT Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Denmark
Department of Cardiology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Annette Schophuus Jensen
Investigators
Layout table for investigator information
Principal Investigator: Annette S Jensen, MD, PhD Rigshospitalet, Denmark
Layout table for additonal information
Responsible Party: Annette Schophuus Jensen, PhD MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02716402    
Other Study ID Numbers: H-15012759
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Annette Schophuus Jensen, Rigshospitalet, Denmark:
Cyanotic congenital heart disease
pulmonary thrombosis
cerebral thrombosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases