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Completed

NCT Number: NCT03021382

Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography

The objective of this study is to evaluate the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (cCTA) by current version of HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical coherence tomography (OCT) as reference standard.

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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

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, 650-0017, Japan

About this study

Analysis of cCTA and OCT was conducted under blind in independent organizations.

After unblinding the cCTA and OCT case identification number, the OCT image was co-registered to cCTA data.

After co-registration of cCTA and OCT lesion locations, the minimal lumen area (MLA) was detected with both modalities. FFROCT was calculated using OCT-updated models in which cCTA-based lumen geometry was replaced by OCT-based lumen geometry.

Lesions were grouped according to their severity of calcification (using Agatston score) and minimum lumen diameter.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who underwent cCTA prior to coronary angiography and OCT within 6 months.

Exclusion criteria

  • Prior coronary artery bypass graft (CABG) surgery
  • Contraindication to beta blocker agents or nitrates
  • Tachycardia or significant arrhythmia
  • Impaired chronic renal function (eGFR <30)
  • Subjects with known anaphylactic allergy to iodinated contrast material
  • Pregnancy or unknown pregnancy status in subject of childbearing potential
  • Cases with poor OCT or CCTA image for analyzing

Treatment and study plan

data collection, non-intervention

Other

Primary outcomes

  1. Correlation between cCTA and OCT for MLA measurements

    Time frame: Immediately after OCT scan

Secondary outcomes

  1. Correlation between FFRCT and FFROCT

    Time frame: Immediately after OCT scan

  2. Impact of calcification on the agreement of MLA between OCT and cCTA measurement

    Time frame: Immediately after OCT scan

  3. Impact of calcification on the agreement of FFR between OCT and cCTA

    Time frame: Immediately after OCT scan

Sponsors and collaborators

Lead sponsor

Kobe University

Industry

Collaborators

  • HeartFlow, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2017
Registry last updated
Jan 13, 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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