Myocardial Stress Perfusion Imaging With Dual Source CT

June 5, 2018 updated by: Brian Burns Ghoshhajra, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Adenosine Stress Dual-source CTP

Adenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; Iopamidol (IV contrast)- total dose of 150cc; Siemens SOMATOM Definition CT scanner (CT scan radiation) - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner)

This is an observational trial, and all patients will undergo the Adenosine Stress Dual-source CTP procedure.

Other Names:
  • Adenosine
  • Iopamidol 370
  • Siemens SOMATOM Definition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
Time Frame: 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.
18 months
Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
Time Frame: 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.
18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: Brian B Ghoshhajra, MD, Massachusetts General Hospital
  • Study Director: Ricardo C Cury, MD, Massachusetts General Hospital, Baptist Hospital, Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (Estimate)

March 2, 2009

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSCTSTRESS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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