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Wave Intensity Analysis in the Pulmonary Artery

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ClinicalTrials.gov Identifier: NCT01972009
Recruitment Status : Unknown
Verified October 2013 by Imperial College London.
Recruitment status was:  Not yet recruiting
First Posted : October 30, 2013
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease Intervention/treatment
Pulmonary Hypertension Procedure: Cardiac catheterisation

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Systematic Assessment of Pulmonary Artery Haemodynamics Using Wave Intensity Analysis
Study Start Date : October 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Procedure: Cardiac catheterisation
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.

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.
Procedure: Cardiac catheterisation
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.




Primary Outcome Measures :
  1. Wave reflection coefficient [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Reservoir function [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

- Adult patients undergoing right and left heart catheterisation.

Exclusion Criteria:

  • 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

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): NCT01972009


Contacts
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Contact: Charlotte Manisty, MRCP PHD +44 (0)2075841264 cmanisty@ic.ac.uk
Contact: Junjing Su, MD +44 (0)7462855344 junjingsu@hotmail.com

Locations
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United Kingdom
National Heart and Lung Institute, Imperial College London Not yet recruiting
London, United Kingdom, W2 1LA
Contact: Charlotte Manisty, MRCP PHD    +44 (0) 2075841264    cmanisty@ic.ac.uk   
Contact: Junjing Su, MD    +44 (0) 7462855344    junjingsu@hotmail.com   
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Charlotte Manisty, MRCP PhD National Heart and Lung Institute, Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01972009     History of Changes
Other Study ID Numbers: 13HH0812
13/LO/1305 ( Other Identifier: NRES Committee London - Fulham )
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
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Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases