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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

Tracking Information
First Submitted Date May 5, 2010
First Posted Date May 6, 2010
Last Update Posted Date February 7, 2017
Study Start Date January 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2011)
Correlation and descriptive characteristics between adenosine free measure of stenosis severity and FFR [ Time Frame: Study end ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01118481 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vasodilator Free Measure of Fractional Flow Reserve
Official Title ADenosine Vasodilator Independent Stenosis Evaluation Study (ADVISE)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with coronary stenosis without exclusion criteria
Condition Coronary Stenosis
Intervention Not Provided
Study Groups/Cohorts
  • Pressure and flow velocity
  • Pressure only
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 6, 2017)
157
Original Estimated Enrollment
 (submitted: May 5, 2010)
80
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01118481
Other Study ID Numbers 1428
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Imperial College London
Study Sponsor Imperial College London
Collaborators Hospital San Carlos, Madrid
Investigators
Principal Investigator: Justin E Davies, BSc, MBBS, MRCP, PhD Imperial College London
PRS Account Imperial College London
Verification Date February 2017