Myocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System

NCT02308475 | Terminated Results

• 1 other identifier: Pro31584
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the ability of a novel 3rd generation dual-source CT system to demonstrate myocardial perfusion in a cohort of patients presenting to the Chest Pain Center with acute chest pain.

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Dynamic Perfusion CT

  The diagnostic accuracy of dynamic perfusion CT of the heart for evaluation of perfusion, viability and function during stress and rest will be compared with SPECT myocardial perfusion imaging using p-values for comparison of reader specific values, calculated by means of the McNemar test.

  1 Day

Secondary Outcomes (2)

• CTMP/SPECT MPI Disagreement

  1 Day

• Radiation Dose

  1 Day

Study Arms (1)

Myocardial Stress CT Perfusion

EXPERIMENTAL

Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium.

Device: Somatom Force CT Scanner

Interventions

Somatom Force CT Scanner DEVICE

Dynamic CT perfusion of the heart

Myocardial Stress CT Perfusion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must present with symptoms of acute but atypical or recurrent chest pain.
• 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 conducted.
• Subject must be willing to comply with all clinical study procedures.

You may not qualify if:

• Subject is a pregnant or nursing female.
• 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 or pharmaceutical stressors used in this study.
• Subject suffers from claustrophobia.
• Subject has impaired renal function (creatinine \> 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Brian Jacobs - Program Assistant
• Organization: Medical University of South Carolina

jacobsbr@musc.edu

843-876-4922

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 4, 2014
• Study Start: December 1, 2014
• Primary Completion: July 6, 2015
• Study Completion: July 6, 2015
• Last Updated: July 6, 2018
• Results First Posted: July 6, 2018

Record last verified: 2018-06

Locations

US (1)