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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103061
• Other study ID #: Pro00051308
• Status: Completed
• Phase: Phase 2
• Start date: February 9, 2016
• Est. completion date: June 14, 2018

Study information

• Verified date: July 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 14, 2018
• Est. primary completion date: June 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Lexiscan
Coronary vasodilator

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.