Vasodilator Free Measure of Fractional Flow Reserve (ADVISE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hospital San Carlos, Madrid
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01118481
First received: May 5, 2010
Last updated: September 5, 2011
Last verified: September 2011
  Purpose

Narrowing of coronary arteries interferes with blood flow and can cause chest pain. Cardiologists sometimes quantify the extent of the narrowing by measuring the fractional flow reserve (the ratio of the pressure in the aorta to the pressure downstream of the narrowing under conditions of maximal flow). We propose a new technique based on principles of wave intensity analysis (WIA) to better assess coronary stenosis and the significance of the narrowing without the need for administration of vasodilator agents such as adenosine. This would simplify assessment and improve our ability to advise patients whether stent treatment will help their symptoms.


Condition
Coronary Stenosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: ADenosine Vasodilator Independent Stenosis Evaluation Study (ADVISE)

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Correlation and descriptive characteristics between adenosine free measure of stenosis severity and FFR [ Time Frame: Study end ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2010
Groups/Cohorts
Pressure and flow velocity
Pressure only

  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 with coronary stenosis without exclusion criteria

Criteria

Inclusion Criteria:

  • Patients with coronary stenosis

Exclusion Criteria:

  • Patient's with cardiac pacemakers, valvular heart disease, and chronic renal failure
  • Unable to consent
  • Contraindications to adenosine
  • Contraindications to cardiac MRI
  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: NCT01118481

Contacts
Contact: Justin E Davies, BSC, MBBS, MRCP, PhD 020 7594 1024 justin.davies@imperial.ac.uk
Contact: Sayan Sen 020 7594 33 86 sayan.sen@imperial.ac.uk

Locations
United Kingdom
Imperial College NHS Trust Recruiting
London, United Kingdom
Contact: Justin E Davies, BSc, MBBS, MRCP, PhD    +44 (0)207 594 1024    justin.davies@imperial.ac.uk   
Contact: Sayan Sen, MRCP    020 7594 33 86    sayan.sen@imperial.ac.uk   
Principal Investigator: Justin E Davies, BSc, MBBS, MRCP, PhD         
Sub-Investigator: Sayan Sen, MRCP         
Sponsors and Collaborators
Imperial College London
Hospital San Carlos, Madrid
Investigators
Principal Investigator: Justin E Davies, BSc, MBBS, MRCP, PhD Imperial College London
  More Information

Additional Information:
No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01118481     History of Changes
Other Study ID Numbers: 1428
Study First Received: May 5, 2010
Last Updated: September 5, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Coronary stenosis
Wave intensity analysis
Instantaneous Flow Reserve
iFR
Fractional Flow Reserve

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014