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NCT01118481 Clinical Trial

Vasodilator Free Measure of Fractional Flow Reserve

Coronary Stenosis Clinical Trial

— ADVISE  

Official title:
ADenosine Vasodilator Independent Stenosis Evaluation Study (ADVISE)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01118481
Other study ID # 1428
Secondary ID
Status Completed
Phase N/A
First received May 5, 2010
Last updated February 6, 2017
Start date January 2010
Est. completion date June 2011

Study information
Verified date February 2017
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 157
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Imperial College NHS Trust London

Sponsors (2)
Lead Sponsor Collaborator
Imperial College London Hospital San Carlos, Madrid

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation and descriptive characteristics between adenosine free measure of stenosis severity and FFR Study end
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