Myocardial Stress Perfusion Imaging With Dual Source CT

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Adenosine Stress Dual-source CTP

• Registration Number: NCT00853671
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The investigators propose a novel technique using dual source multidetector computed tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary plaque as well as assess the functional significance of a stenosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-02-27
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-02
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2010-05-18
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-05
• Last Update Submitted: 2018-06-05
• Results First Posted: 2018-12-17
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• A prior adenosine or exercise stress SPECT exam with high likelihood of being referred to the cardiac catheterization laboratory for invasive angiogram
• Age > 40 years old
• Able to comprehend and sign the consent form.

Exclusion Criteria

• Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction)
• Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
• Premenopausal women who have a positive pregnancy test.
• Serum Creatinine level ≥1.5 mg/dl as an indicator of renal insufficiency.
• Known allergy to iodinated contrast agents
• Atrial fibrillation
• Asthma
• Critical aortic stenosis
• Systolic blood pressure < 90 mmHg
• Advanced heart block

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adenosine Stress Dual-source CTP	Adenosine Stress Dual-source CTP	A multiphase adenosine Stress Dual-source stress perfusion computed tomography imaging test, as described above, will be performed in all patients.

Primary Outcome Measures

Name	Time	Method
Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.	18 months	The gold standard for abnormality by CTP is defined as a focal stenosis of \>50% at quantitative analysis of invasive coronary angiography images, when performed.
Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.	18 months	The gold standard for abnormality by CTP is defined as stenosis of 50% or more at quantitative analysis of invasive coronary angiography images, when performed.

Secondary Outcome Measures

Name	Time	Method
Per-Patient Correlation Between CTP and SPECT at Stress.	18 months	Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress.
Per-Patient Correlation Between CTP and SPECT at Rest.	18 months	Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States