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Vasodilator Free Measure of Fractional Flow Reserve (ADVISE)

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ClinicalTrials.gov Identifier: NCT01118481
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
Hospital San Carlos, Madrid
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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 or disease
Coronary Stenosis

Study Type : Observational
Actual Enrollment : 157 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: ADenosine Vasodilator Independent Stenosis Evaluation Study (ADVISE)
Study Start Date : January 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Group/Cohort
Pressure and flow velocity
Pressure only



Primary Outcome Measures :
  1. Correlation and descriptive characteristics between adenosine free measure of stenosis severity and FFR [ Time Frame: Study end ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01118481


Locations
United Kingdom
Imperial College NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Hospital San Carlos, Madrid
Investigators
Principal Investigator: Justin E Davies, BSc, MBBS, MRCP, PhD Imperial College London

Additional Information:
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
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

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