Clinical trial NCT01118481: Vasodilator Free Measure of Fractional Flow Reserve
Official title: ADenosine Vasodilator Independent Stenosis Evaluation Study (ADVISE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Stenosis
Keywords: Coronary stenosis
Wave intensity analysis
Instantaneous Flow Reserve
iFR
Fractional Flow Reserve
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Hospital San Carlos, Madrid
First posted: 2010-05-06
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary stenosis without exclusion criteria

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.


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

Primary outcomes:
measure: Correlation and descriptive characteristics between adenosine free measure of stenosis severity and FFR
timeFrame: Study end
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College NHS Trust
Study officials:
affiliation: Imperial College London
name: Justin E Davies, BSc, MBBS, MRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sen S, Asrress KN, Nijjer S, Petraco R, Malik IS, Foale RA, Mikhail GW, Foin N, Broyd C, Hadjiloizou N, Sethi A, Al-Bustami M, Hackett D, Khan MA, Khawaja MZ, Baker CS, Bellamy M, Parker KH, Hughes AD, Francis DP, Mayet J, Di Mario C, Escaned J, Redwood S, Davies JE. Diagnostic classification of the instantaneous wave-free ratio is equivalent to fractional flow reserve and is not improved with adenosine administration. Results of CLARIFY (Classification Accuracy of Pressure-Only Ratios Against Indices Using Flow Study). J Am Coll Cardiol. 2013 Apr 2;61(13):1409-20. doi: 10.1016/j.jacc.2013.01.034.
citation: Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.