Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET (IDEALPET)

September 27, 2018 updated by: Sharmila Dorbala, MBBS, Brigham and Women's Hospital

Integrated Dual Exercise and Lexiscan PET: IDEAL PET

This is a single-center study of subjects undergoing clinically indicated heart scans for evaluation of known or suspected heart disease. We will also include 10 healthy subjects without known heart disease. We would like to study stress testing of the heart using exercise and a medication called regadenoson. Imaging of the heart will be performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Regadenoson is stress agent approved by the FDA for use with myocardial perfusion imaging with technetium-99m single photon emission computed tomography (SPECT) in patients that are unable to exercise adequately. We would like to study Regadenoson in conjunction with Exercise Rubidium-82 positron emission tomography myocardial perfusion imaging (PET MPI). Regadenoson is not approved by FDA for use with Rubidium-82 PET MPI. Also, we would like to study a novel stress protocol of Regadenoson combined with symptom limited exercise stress (not FDA approved).

The objectives of this study are to assess the tolerability and safety of combined symptom limited exercise stress test with Lexiscan (Lexercise PET) compared to Lexiscan alone (Lexiscan PET), to assess image quality of Lexercise compared to Lexiscan PET and to compare relative and absolute myocardial perfusion imaging with Lexercise compared to Lexiscan PET to identify CAD.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

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, 02421
        • Brigham and Womens' 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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years
  • Clinically indicated N-13 ammonia PET study or ten healthy volunteers
  • Known coronary artery disease (prior percutaneous coronary intervention, prior coronary artery bypass surgery or Q wave MI on ECG) or intermediate to high pretest likelihood of CAD
  • Able to exercise on a treadmill
  • Able and willing to provide informed consent to participate in the study

Exclusion Criteria:

  • Contraindications to exercise stress testing such as, unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure < 90 or > 200 mmHg, respectively), or > 1st degree atrioventricular block in the absence of a functioning pacemaker.
  • Subject requires emergent cardiac medical intervention or catheterization after the clinical study.
  • Documented myocardial infarction (MI) ≤ 30 days prior to enrollment.
  • History of percutaneous coronary intervention (PCI) ≤ 4weeks prior to enrollment.
  • History of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment.
  • History of heart transplantation.
  • Allergy or intolerance to aminophylline or regadenoson
  • Known severe or oxygen dependent bronchoconstrictive or bronchospastic lung disease [e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.].
  • Severe LV dysfunction, with ejection fraction of < 30%
  • Serious non-cardiac medical illness (e.g., disseminated malignancy, severe neurological dysfunction at time of baseline PET study) or a social situation which will preclude research study participation
  • History of Seizures.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Regadenoson (Lexiscan)
Regadenoson Rubidium-82 Positron Emission Tomography
Drug: Regadenoson (Lexiscan)
Regadenoson Rubidium-82 Positron Emission Tomography
Experimental: Exercise + Regadenoson (Lexercise)
Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography
Drug: Exercise plus Regadenoson (Lexercise)
Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
Other Names:
  • Exercise plus Lexiscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Combined Exercise and Regadenoson Stress
Time Frame: Day of the research scan during the stress test
  1. Count of subjects with ischemic ECG changes is reported
  2. Count of subjects with systolic blood pressure decrease > 20 mm Hg is reported
  3. Count of subjects with abnormal serum troponin T levels is reported
  4. Radiation dose to the staff will be measured using personal dosimeters after the Lexiscan as well as the Lexercise PET study.
Day of the research scan during the stress test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Quality: Heart to Liver Ratio of Counts
Time Frame: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)

Sub-diaphragmatic activity: Heart to Liver Ratio was measured on the rubidium-82 and N-13 ammonia scans. Since this measure is a ratio it has no units. Mean and Standard Deviation of Ratio is reported for each group.

This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.
Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET
Time Frame: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)

Left ventricular ejection fraction (LVEF) at stress was measured at Stress scan 1 (regadenoson) and Stress scan 2 (regadenoson or exercise + regadenoson).

This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.
Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Peak Stress Myocardial Blood Flow
Time Frame: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Myocardial Blood Flow Measured at Peak Hyperemia With Regadenoson or Immediately After Exercise + Regadenoson This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.
Week 1 (day of the clinical scan), and Week 2 (day of the research scan)

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Sharmila Dorbala, MBBS, Brigham and Women's Hospital

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

February 1, 2011

Primary Completion (Actual)

June 6, 2017

Study Completion (Actual)

June 6, 2017

Study Registration Dates

First Submitted

April 16, 2010

First Submitted That Met QC Criteria

April 22, 2010

First Posted (Estimate)

April 23, 2010

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWH

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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