NCT02716402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

March 8, 2016

Last Update Submit

August 27, 2018

Conditions

Thrombosis

Keywords

Cyanotic congenital heart diseasepulmonary thrombosiscerebral thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The total numbers of white matter hyper intensity lessons (WMHL)

    Through study completion, an average of 1 year

  • The size of the white matter hyper intensity lessons (WMHL)

    Through study completion, an average of 1 year

Study Arms (1)

Cyanotic congenital heart disease

OTHER

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

Interventions

Cerebral MRI and V/Q SPECT/CTRADIATION

Cerebral MRI and V/Q SPECT/CT

Cyanotic congenital heart disease

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who are not guardians for themselves (not adult).
  • Age \<18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

ThrombosisIntracranial Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesIntracranial Embolism and ThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesThromboembolism

Study Officials

  • Annette S Jensen, MD, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD MD

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 23, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2017

Study Completion

November 1, 2017

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)