Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103061
Recruitment Status : Completed
First Posted : April 6, 2017
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
U. Joseph Schoepf, MD, Medical University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Artery Disease Drug: Lexiscan Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Stress and rest perfusion imaging using Lexiscan as the coronary vasodilator (pharmacological stressor).
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
Actual Study Start Date : February 9, 2016
Actual Primary Completion Date : June 14, 2018
Actual Study Completion Date : June 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
Drug Information available for: Regadenoson

Arm Intervention/treatment
Experimental: Myocardial Stress CT Perfusion
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. Lexiscan(TM) will be used as the pharmacological stress agent (coronary vasodilator).
Drug: Lexiscan
Coronary vasodilator




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must present with symptoms (e.g. chest pain) suspicious for cardiac ischemia as determined by treating physician.
  2. 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.
  3. Subject must be 18 - 85 years of age.
  4. Subject must provide written informed consent prior to any study-related procedures being performed.
  5. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

  1. 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.
  2. Subject has severe asthma or COPD requiring frequent inhaler use.
  3. Subject has prior diagnosis of obstructive CAD that has not been revascularized.
  4. Subject with implanted rhythm devices (pacemaker, defibrillator).
  5. Subject has significant arrhythmia.
  6. Subject has high grade heart block.
  7. Subject has resting heart rate < 45 bpm, systolic blood pressure <90 mm Hg, or has consumed caffeine within the last 12 hours.
  8. Subject has an acute psychiatric disorder.
  9. Subject is unwilling to comply with the requirements of the protocol.
  10. Subject has previously entered this study.
  11. Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
  12. Subject suffers from claustrophobia.
  13. Subject has impaired renal function (creatinine > 1.5 mg/dl).
  14. Subject is in unstable condition.
  15. ST-elevations, new transient ST changes greater than 0.05mV or T- wave inversions with symptoms
  16. Subject cannot safely be administered Lexiscan™ per prescribing information as determined by investigator
  17. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103061


Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Astellas Pharma US, Inc.
  Study Documents (Full-Text)

Documents provided by U. Joseph Schoepf, MD, Medical University of South Carolina:
Layout table for additonal information
Responsible Party: U. Joseph Schoepf, MD, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03103061    
Other Study ID Numbers: Pro00051308
First Posted: April 6, 2017    Key Record Dates
Results First Posted: August 9, 2019
Last Update Posted: August 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by U. Joseph Schoepf, MD, Medical University of South Carolina:
Computed Tomography
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs