Determination of Instantaneous Wave-Free Ratio by Computed Tomography

NCT01747031 | Unknown DMC

• 1 other identifier: NCT20121204
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The iFRCT study is a prospective, multicenter study to evaluate the diagnostic performance of iFRCT with the use of ≥64-detector row CT scanners for the detection and exclusion of significant obstructive coronary artery disease, defined by invasive fractiona flow reserve (FFR) as the reference standard.

Conditions

Coronary Artery Disease

Keywords

iFR; FFR; instantaneous wave-free ratio; fractional flow reserve

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of iFRCT

  Diagnostic accuracy\[Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)\]\* of CCTA plus iFRCT(instantaneous wave-free ratio calculated in reconstructed heart model) or iFRCT alone to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis at the subject level using binary outcomes when compared to FFR as the reference standard.\*Sensitivity measures the proportion of actual positives which are correctly identified. Specificity measures the proportion of negatives which are correctly identified;PPV, or precision rate is the proportion of positive test results that are true positives (such as correct diagnoses);NPV is defined as the proportion of subjects with a negative test result who are correctly diagnosed.

  1 day

Secondary Outcomes (5)

• Diagnostic accuracy of iFRCT at the subject level

  1 day

• Diagnostic accuracy of iFRCT at the vessel level

  1 day

• FFR Numerical Correlation

  1 day

• FFRCT Numerical Correlation

  1 day

• Predicted Post-PCI FFR Measurement

  1 day

Study Arms (1)

Single arm study

EXPERIMENTAL

Single arm study.The investigators will conducte computed tomography,angiography and FFR measurement during angiography in this single arm.

Device: PressureWire™ Certus(St. Jude Medical Systems, Sweden)

Interventions

PressureWire™ Certus(St. Jude Medical Systems, Sweden) DEVICE

Fractional flow reserve measured during cardiac catheterization--A pressure-monitoring guidewire(PressureWire Certus, St. Jude Medical Systems, Uppsala, Sweden) will be advanced past the stenosis.

Single arm study

Eligibility Criteria

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

You may qualify if:

• Coronary computed tomographic angiography(CCTA) with over 50 percent stenosis in a major coronary artery over 2mm diameter
• Undergoing clinically indicated invasive coronary angiography with FFR

You may not qualify if:

• A history of CABG surgery
• Prior percutaneous coronary intervention with suspected instent restenosis
• Suspicion of or recent acute coronary syndrome
• Complex congenital heart disease
• Prior pacemaker or defibrillator
• Prosthetic heart valve
• Significant arrhythmia
• heart rate \>100 beats/min
• systolic blood pressure≤90 mmHg
• contraindication to beta blockers, nitroglycerin or adenosine
• Serum creatinine level greater than 1.5 mg per dL
• Allergy to iodinated contrast
• Pregnant state
• Body mass index greater than 35
• Evidence of active clinical instability or lifethreatening disease

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, 200072, China

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ya-Wei Xu, MD, FACC

  Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FACC

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 11, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

CN (1)