Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR

February 14, 2017 updated by: Toshiba Medical Systems Corporation, Japan

Clinical Trial for SURECardio CT-FFR

The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CT acquision and invasive FFR measurement is performed for each patients. The diagnostic accuracy of coronary CTA and SURECardio CT-FFR is investigated using Invasive FFR is used as the reference standard.

Study Type

Observational

Enrollment (Actual)

59

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Suspected coronary artery disease

Description

Inclusion Criteria:

  • suspected coronary artery disease
  • hemodynamically stable condition

Exclusion Criteria:

  • hemodynamic instability
  • atrial fibrillation
  • morbid obesity (BMI≥40 kg/m2)
  • previous stent implantation
  • recent myocardial infarction (within 30 days)
  • age <40 years
  • renal insufficiency (eGFR <60mL/min/1.73m2)
  • bronchospastic lung disease requiring long term steroid therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CT-FFR. CTA. FFR
59 patients with suspected CAD that have been scheduled for an interventional FFR study
Device: CT-FFR. CTA. FFR
Study is to compare results of CT FFR against CTA and interventional FFR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toshiba Medical Systems Corporation, Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

May 30, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

February 14, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGD03-0667

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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