Vasodilator Free Measure of Fractional Flow Reserve

NCT01118481 | Completed DMC

• 1 other identifier: 1428
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Stenosis

Keywords

Coronary stenosis; Wave intensity analysis; Instantaneous Flow Reserve; iFR; Fractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

• Correlation and descriptive characteristics between adenosine free measure of stenosis severity and FFR

  Study end

Study Arms (2)

Pressure and flow velocity

Pressure only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary stenosis without exclusion criteria

You may qualify if:

• Patients with coronary stenosis

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead
• Hospital San Carlos, Madrid: collaborator

Study Sites (1)

Imperial College NHS Trust

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 23500218 DERIVED

• 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.

  PMID: 22154731 DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Justin E Davies, BSc, MBBS, MRCP, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 6, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

GB (1)