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Completed

NCT Number: NCT03103061

Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System

The purpose of this study is to evaluate the feasibility, tolerability, safety, and image quality of low-radiation, dynamic perfusion CT of the heart in patients with suspected ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Secondary aims include the assessment of the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject must present with symptoms (e.g. chest pain) suspicious for cardiac ischemia as determined by treating physician.
  • Subject must have been referred for cardiac CT angiography OR subject must have undergone clinically indicated SPECT with positive or equivocal findings OR subject must have undergone clinically indicated SPECT with prior cardiac CT angiography that showed moderate or severe stenosis.
  • Subject must be 18 - 85 years of age.
  • Subject must provide written informed consent prior to any study-related procedures being performed.
  • Subject must be willing to comply with all clinical study procedures.

Exclusion criteria

  • Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
  • By testing (serum or urine beta HCG) within 24 hours before study agent administration, or
  • By surgical sterilization, or
  • Post menopausal, with minimum one (1) year history without menses.
  • Subject has severe asthma or COPD requiring frequent inhaler use.
  • Subject has prior diagnosis of obstructive CAD that has not been revascularized.
  • Subject with implanted rhythm devices (pacemaker, defibrillator).
  • Subject has significant arrhythmia.
  • Subject has high grade heart block.
  • Subject has resting heart rate < 45 bpm, systolic blood pressure <90 mm Hg, or has consumed caffeine within the last 12 hours.
  • Subject has an acute psychiatric disorder.
  • Subject is unwilling to comply with the requirements of the protocol.
  • Subject has previously entered this study.
  • Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
  • Subject suffers from claustrophobia.
  • Subject has impaired renal function (creatinine > 1.5 mg/dl).
  • Subject is in unstable condition.
  • ST-elevations, new transient ST changes greater than 0.05mV or T- wave inversions with symptoms
  • Subject cannot safely be administered Lexiscan™ per prescribing information as determined by investigator
  • Subject has received interventional (PCI, stenting) or surgical (CABG) treatment that may alter the cardiac condition regarding myocardial perfusion status and/or stenosis degree between cardiac CTA, SPECT, and/or CT stress perfusion studies.

Treatment and study plan

Lexiscan

Drug

Coronary vasodilator

Primary outcomes

  1. Number of Treatment-related Adverse Events

    Time frame: 30 days +/- 3 days

    Demonstrate that CTA with stress and rest perfusion imaging using Lexiscan as the coronary vasodilator will be safe and well tolerated.

    This outcome measure data value represents the number of adverse events that occurred during this study.

Secondary outcomes

  1. Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment

    Time frame: Immediately following CT perfusion imaging.

    Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Aug 9, 2019

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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