Diagnostic Accuracy of Cardiac CT Perfusion Compared to PET Imaging

NCT01434043 | Completed

• 1 other identifier: STUDY00001616
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This purpose of this research project is to test the diagnostic accuracy (i.e., sensitivity, specificity, positive and negative predictive value, and receiver operator curve area under the curve) of cardiac computed tomography (CT) perfusion as compared to the best non-invasive test of blood flow -- cardiac positron emission transmission (PET) perfusion imaging. The primary outcome of the study is to determine the CT perfusion technique with the highest overall diagnostic accuracy measured by the highest area under the receiver operator curve. The investigators will test 4 different CT perfusion techniques. (A) Qualitative, visual inspection of the contrast-enhanced CT images (B) Enhanced voxel distribution analysis (C) Rate of myocardial contrast enhancement analysis (D) Quantitative heart blood flow using a distributed 2-region analysis A second aim is to reduce the radiation dose needed to maintain CT perfusion diagnostic accuracy. Using the CT perfusion data, the investigators will model the minimal number of cardiac cycle radiation exposures needed to keep the diagnostic accuracy similar to the full data set. A third aim is to test the incremental diagnostic accuracy of CT angiography plus CT perfusion to identify regions of low blood flow as compared to PET perfusion alone.

Conditions

Myocardial Ischemia; Coronary Artery Disease; Myocardial Infarction

Keywords

Cardiac CT perfusion; Positron emission tomography perfusion; Quantitative perfusion

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy measures of cardiac CT perfusion techniques

  Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the curve \[ROC AUC\]. The highest ROC AUC will be considered the best diagnostic performance and will be compared statisically using the c-statistic.

  1 month

Secondary Outcomes (2)

• Minimal number of images needed for CT perfusion

  1 month

• Diagnostic accuracy of CCTA and CT perfusion compared to PET perfusion imaging alone

  1 month

Study Arms (1)

Myocardial ischemia patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with suspected or known myocardial ischemia

You may qualify if:

• Patients referred for
• clinically indicated PET imaging for assessment of myocardial ischemia
• clinically indicated CCTA scanning with known coronary artery disease
• ≥20 years of age and ≤ 80 years of age
• Able to provide written informed consent

You may not qualify if:

• Contraindications to beta blockers or regadenoson
• Active reactive airway disease
• nd or 3rd degree heart block (without a pacemaker)
• Sick sinus syndrome (without a pacemaker)
• Long QT syndrome (QTC \> 500 msec)
• Severe hypotension
• Decompensated heart failure
• Pregnancy
• Contraindications to undergoing any CT imaging procedure with contrast:
• Irregular heart rhythm despite beta blockade
• Creatinine \>1.6 mg/dl
• Allergy to iodinated contrast medium
• Inability to lie flat

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medicine/Cardiology

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 14, 2011
• Study Start: September 1, 2011
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2019
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

US (1)