Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01118442
First received: May 5, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

Narrowing of the main valve which controls blood leaving the heart leads to a marked increase in death. To overcome this narrowing the heart muscle thickens abnormally and contracts more vigorously. However, in doing so, blood flow patterns to the heart muscle change through mechanisms which are incompletely understood. New technology allows such heart valve blockages to be fixed using balloons and metal stents inserted through tubes placed in arteries in the leg. Using sensors placed in these tubes it is possible to make detailed measurements of coronary flow and pressure, and apply new mathematical techniques to allow a better understanding of the detrimental effects that aortic stenosis has on coronary flow, before and after valve surgery.


Condition
Aortic Valve Stenosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Biospecimen Retention:   Samples With DNA

Myocardial biopsy specimens


Estimated Enrollment: 6
Study Start Date: December 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing transcutaneous aortic valve insertion who meet study criteria

Criteria

Inclusion Criteria:

  • Severe Aortic Stenosis undergoing TAVI
  • Normal coronary arteries
  • Normal left ventricular function
  • No other valvular pathology

Exclusion Criteria:

  • Unable to consent
  • Left ventricular impairment
  • Left ventricular regional wall motion abnormality
  • Other valve abnormality
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118442

Contacts
Contact: Justin E Davies, MRCP, PhD 020 7594 33 86 justin.davies@imperial.ac.uk
Contact: Sayan Sen, MRCP 020 7594 33 86 sayan.sen@imperial.ac.uk

Locations
United Kingdom
Imperial College NHS Trust Recruiting
London, United Kingdom
Contact: Justin E Davies, MRCP, PhD    020 7594 33 86    justin.davies@imperial.ac.uk   
Contact: Sayan Sen, MRCP    020 7594 33 86    sayan.sen@imperial.ac.uk   
Principal Investigator: Justin E Davies, MRCP, PhD         
Sub-Investigator: Sayan Sen, MRCP         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Justin E Davies, MRCP PhD Imperial College London
  More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Justin E Davies, Imperial College London
ClinicalTrials.gov Identifier: NCT01118442     History of Changes
Other Study ID Numbers: 1424
Study First Received: May 5, 2010
Last Updated: May 5, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Aortic Stenosis
Coronary Flow
Wave Intensity Analysis

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 30, 2014