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OpenTrials
Completed

NCT Number: NCT03055780

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

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

Completed

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT-FFR. CTA. FFR

Device

Study is to compare results of CT FFR against CTA and interventional FFR

Primary outcomes

  1. Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Toshiba Medical Systems Corporation, Japan

Industry

Registry information

Official study title

Clinical Trial for SURECardio CT-FFR

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 16, 2017
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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