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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease
• Intervention / Treatment: Drug: Lexiscan

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment-related Adverse Events	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.	30 days +/- 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment	Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.	Immediately following CT perfusion imaging.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Astellas Pharma US, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2016
• Primary Completion (Actual): June 14, 2018
• Study Completion (Actual): June 14, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Computed Tomography
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Cardiovascular Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine A2 Receptor Agonists; Regadenoson
• Other Study ID Numbers: Pro00051308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO