CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Lexiscandrug
Likely dose
Lexiscan (regadenoson) per standard coronary vasodilator dosing for pharmacologic stress testingAI-extracted
Key inclusion· 3
  • ✓Age 18–85 years
  • ✓Symptoms suspicious for cardiac ischemia (e.g. chest pain) as determined by treating physician
  • ✓Referred for cardiac CT angiography OR prior SPECT with positive/equivocal findings OR prior SPECT and cardiac CTA showing moderate/severe stenosis
Key exclusion· 14
  • ✕Pregnant or nursing female
  • ✕Severe asthma or COPD requiring frequent inhaler use
  • ✕Prior obstructive CAD not revascularized
  • ✕Implanted rhythm devices (pacemaker, defibrillator)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03103061
NCT03103061Phase 2Completed
CompareCT.gov

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

Medical University of South Carolina·interventional·Posted Apr 6, 2017·Updated Aug 9, 2019

In Brief

A Phase 2 clinical trial evaluating Lexiscan for Cardiovascular Diseases and Coronary Artery Disease. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Coronary Artery Disease
CountriesUnited States
CollaboratorsAstellas Pharma US, Inc.

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 6, 2017
Enrollment StartFeb 9, 2016
Primary CompletionJun 14, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.2 years ago

Interventions

Lexiscandrug

Coronary vasodilator