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Completed

NCT Number: NCT02716402

Cyanotic Heart Disease and Thrombosis

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.

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Key information

Conditions

Thrombosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Intracranial Embolism and Thrombosis Intracranial Thrombosis Nervous System Diseases Thromboembolism Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cerebral MRI and V/Q SPECT/CT

Radiation

Cerebral MRI and V/Q SPECT/CT

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Annette Schophuus Jensen

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2016
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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