Wave Intensity Analysis in the Pulmonary Artery
Systematic Assessment of Pulmonary Artery Haemodynamics Using Wave Intensity Analysis
2 other identifiers
observational
36
1 country
1
Brief Summary
The mechanism governing how blood flows from the heart to the lungs depends on many factors including the pumping function of the right ventricle, properties of the arteries that carry the blood from the right ventricle to the lungs (pulmonary arteries), and the lungs themselves. Under normal conditions the pressure in the pulmonary arteries is well controlled and significantly lower than in the systemic circulation, however there are a number of conditions that lead to abnormally high pressures and significant morbidity and mortality. However different patients respond differently to similarly elevated pressures, leading doctors to believe that there must be differences in either the right ventricles, the properties of the arteries, or the lungs themselves. It can be difficult to determine the relative contributions of each of these factors on blood flow because their effects are superimposed on each other. One approach that has been used to look at this in other parts of the circulation (including in the systemic circulation and the coronary arteries) is to measure simultaneous pressure and flow, and apply a technique called wave intensity analysis (WIA). This technique can amongst other things, quantify the separate effects of wave reflection and the 'reservoir function' (or compliance) of the arteries, and in the systemic circulation WIA has increased the understanding of the mechanisms behind hypertension and the physiological changes of ageing. The pulmonary arteries are accepted to be very different from the systemic circulation and the mechanisms behind pulmonary hypertension are thought to be very different to those of systemic hypertension. This protocol aims to determine the major influences on blood flow in the pulmonary arteries in health and disease, to help to understand why some patients are affected more than others by elevated pulmonary pressures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 24, 2013
CompletedFirst Posted
Study publicly available on registry
October 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 1, 2013
October 1, 2013
1.9 years
October 24, 2013
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Wave reflection coefficient
6 months
Secondary Outcomes (1)
Reservoir function
6 months
Study Arms (2)
Subjects without pulmonary hypertension
Patients with normal pulmonary pressures will be recruited amongst patients who are on the waiting list awaiting routine cardiac catheterisation for the investigation of shortness of breath and chest pain.
Subjects with pulmonary hypertension
Patients with pulmonary hypertension will be recruited from the National Pulmonary Hypertension Service who are awaiting right and left heart catheterisation studies as part of their routine diagnostic work-up.
Interventions
Simultaneous measurement of pressure and flow velocity in the pulmonary artery is achieved during right heart catheterisation by passing a catheter as per usual practice into the pulmonary artery, a purpose-designed wire (Combiwire) will then be advanced approximately 1 cm beyond the end of the catheter. The data obtained will be used for wave intensity analysis.
Eligibility Criteria
Patients with normal pulmonary pressures will be recruited from patients who are on the waiting list awaiting routine cardiac catheterisation at Hammersmith Hospital for the investigation of shortness of breath and chest pain. Patients with pulmonary hypertension will be recruited from the National Pulmonary Hypertension Service, Hammersmith Hospital, who are awaiting right and left heart catheterisation studies as part of their routine diagnostic work up.
You may qualify if:
- \- Adult patients undergoing right and left heart catheterisation.
You may not qualify if:
- under 18 years of age
- atrial fibrillation
- chronic renal failure (eGFR \<30)
- unable to exercise
- unable to consent
- pulmonary embolism in the last 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Heart and Lung Institute, Imperial College London
London, London, W2 1LA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charlotte Manisty, MRCP PhD
National Heart and Lung Institute, Imperial College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2013
First Posted
October 30, 2013
Study Start
October 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
November 1, 2013
Record last verified: 2013-10