Phase 2
N=24
Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
Cardiovascular Diseases · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03103061 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Number of Treatment-related Adverse Events — 6 Adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lexiscan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment-related Adverse Events |
6 | — |
| SECONDARY Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment |
85.7; 70.6; 75 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03103061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.