NCT03103061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 cardiovascular-diseases

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 9, 2019

Completed
Last Updated

August 9, 2019

Status Verified

July 1, 2019

Enrollment Period

2.3 years

First QC Date

March 28, 2017

Results QC Date

June 5, 2019

Last Update Submit

July 18, 2019

Conditions

Cardiovascular DiseasesCoronary Artery Disease

Keywords

Computed Tomography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment

    Immediately following CT perfusion imaging.

Study Arms (1)

Myocardial Stress CT Perfusion

EXPERIMENTAL

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

Interventions

LexiscanDRUG

Coronary vasodilator

Myocardial Stress CT Perfusion

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 \< 45 bpm, systolic blood pressure \<90 mm Hg, or has consumed caffeine within the last 12 hours.
  • Subject has an acute psychiatric disorder.
  • Subject is unwilling to comply with the requirements of the protocol.
  • Subject has previously entered this study.
  • Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
  • Subject suffers from claustrophobia.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery Disease

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Hunter Gray, Program Coordinator
Organization
Medical University of South Carolina
grayhu@musc.edu
843-876-3185

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Stress and rest perfusion imaging using Lexiscan as the coronary vasodilator (pharmacological stressor).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 6, 2017

Study Start

February 9, 2016

Primary Completion

June 14, 2018

Study Completion

June 14, 2018

Last Updated

August 9, 2019

Results First Posted

August 9, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)