Integrated Computational modelIng of Right Heart Mechanics and Blood Flow Dynamics in Congenital Heart Disease

NCT03217240 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2017-07-14

No results posted yet for this study

Summary

Advances in paediatric cardiology and cardiac surgery have enabled the survival of most patients born with congenital heart disease (CHD) into adulthood. Many CHD patients have undergone palliative or reparative surgery earlier in life. As patients survive into adulthood, they may need intervention or surgery for residual haemodynamic lesions. This is because they are at risk of arrhythmias secondary to structure heart disease and are susceptible to acquired heart disease. In these patients, pre-operative and post-operative evaluation of right ventricular (RV) structure (shape and volume) and function is an essential component of clinical management.

Advances have been made in cardiac imaging so that accurate assessment of the right heart chamber in terms of its structure, function and physiology is possible. However, this technology has as yet never been applied in an effort to comprehensively assess RV structure, function and physiology. Cardiac Magnetic Resonance (CMR) will be used in this comprehensive assessment of structure and function. Thus, this research will allow development of a comprehensive integrated biomedical engineering (BME) R\&D platform for in-depth study and clinical diagnosis of the RV structure-function relationship and physiology and its association with biomarker, and exercise capacity in CHD.

Conditions

  • Congenital Heart Disease
  • Pulmonary Hypertension

Interventions

PROCEDURE

Cardiac Magnetic Resonance - MRI

All participants will have to undergo CMR which uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images. Participants will be asked to lie on a narrow bed placed inside of a large magnet for about 1 hour. Several sets of images are needed. Participants are required to stay very still and follow the instruction of the MRI technologist who operates the machine from a room next door.

OTHER

Cardiopulmonary Exercise Test

Participants will be asked to undergo a cardiopulmonary exercise test (CPET). Participants will need to wear a mask. Several electrodes will be placed on the chest to record heart activity during exercise. Participants will need to pedal for at least 8-12 minutes. Pedalling will be instructed to report any symptoms such as chest discomfort, shortness of breath, leg fatigue or dizziness. A small probe will be placed on participant's finger during the test to measure the oxygen content in the blood. Immediately after exercising, participants will rest for 5-10 minutes while the blood pressure and electrocardiogram are monitored. The results will be read by a cardiologist.

OTHER

Blood Sampling for all participants

Serum samples will be obtained before CMR. The sample will be stored at -80 degree until assay. Investigators will perform various tests related to participants heart function

Sponsors & Collaborators

  • Ministry of Health, Singapore

    collaborator OTHER_GOV
  • National Heart Centre Singapore

    lead OTHER

Principal Investigators

  • Dr Zhong Liang · Researcher

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2019-01-31
Completion
2019-08-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217240 on ClinicalTrials.gov