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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Exercise plus Regadenoson (Lexercise)

Regadenoson (Lexiscan)

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary artery disease, exercise, regadenoson, positron emission tomography

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Brigham and Womens' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Regadenoson (Lexiscan)

Exercise + Regadenoson (Lexercise)

Arm Description

Regadenoson Rubidium-82 Positron Emission Tomography

Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography

Outcomes

Primary Outcome Measures

Safety and Tolerability of Combined Exercise and Regadenoson Stress

Count of subjects with ischemic ECG changes is reported Count of subjects with systolic blood pressure decrease > 20 mm Hg is reported Count of subjects with abnormal serum troponin T levels is reported Radiation dose to the staff will be measured using personal dosimeters after the Lexiscan as well as the Lexercise PET study.

Secondary Outcome Measures

Image Quality: Heart to Liver Ratio of Counts

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.

Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET

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.

Peak Stress Myocardial Blood Flow

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.

Full Information

NCT ID

NCT01109992

First Posted

April 16, 2010

Last Updated

September 27, 2018

Sponsor

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01109992

Brief Title

Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET

Acronym

IDEALPET

Official Title

Integrated Dual Exercise and Lexiscan PET: IDEAL PET

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

June 6, 2017 (Actual)

Study Completion Date

June 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

coronary artery disease, exercise, regadenoson, positron emission tomography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Regadenoson (Lexiscan)

Arm Type

Active Comparator

Arm Description

Regadenoson Rubidium-82 Positron Emission Tomography

Arm Title

Exercise + Regadenoson (Lexercise)

Arm Type

Experimental

Arm Description

Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography

Intervention Type

Drug

Intervention Name(s)

Exercise plus Regadenoson (Lexercise)

Other Intervention Name(s)

Exercise plus Lexiscan

Intervention Description

Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography

Intervention Type

Drug

Intervention Name(s)

Regadenoson (Lexiscan)

Intervention Description

Regadenoson Rubidium-82 Positron Emission Tomography

Primary Outcome Measure Information:

Title

Safety and Tolerability of Combined Exercise and Regadenoson Stress

Description

Time Frame

Day of the research scan during the stress test

Secondary Outcome Measure Information:

Title

Image Quality: Heart to Liver Ratio of Counts

Description

Time Frame

Week 1 (day of the clinical scan), and Week 2 (day of the research scan)

Title

Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET

Description

Time Frame

Week 1 (day of the clinical scan), and Week 2 (day of the research scan)

Title

Peak Stress Myocardial Blood Flow

Description

Time Frame

Week 1 (day of the clinical scan), and Week 2 (day of the research scan)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharmila Dorbala, MBBS

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Womens' Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02421

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15837254

Citation

Chow BJ, Ananthasubramaniam K, dekemp RA, Dalipaj MM, Beanlands RS, Ruddy TD. Comparison of treadmill exercise versus dipyridamole stress with myocardial perfusion imaging using rubidium-82 positron emission tomography. J Am Coll Cardiol. 2005 Apr 19;45(8):1227-34. doi: 10.1016/j.jacc.2005.01.016.

Results Reference

background

PubMed Identifier

17372188

Citation

Di Carli MF, Hachamovitch R. New technology for noninvasive evaluation of coronary artery disease. Circulation. 2007 Mar 20;115(11):1464-80. doi: 10.1161/CIRCULATIONAHA.106.629808. No abstract available.

Results Reference

background

PubMed Identifier

12975245

Citation

Klocke FJ, Baird MG, Lorell BH, Bateman TM, Messer JV, Berman DS, O'Gara PT, Carabello BA, Russell RO Jr, Cerqueira MD, St John Sutton MG, DeMaria AN, Udelson JE, Kennedy JW, Verani MS, Williams KA, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Society for Nuclear Cardiology. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines for the Clinical Use of Cardiac Radionuclide Imaging). Circulation. 2003 Sep 16;108(11):1404-18. doi: 10.1161/01.CIR.0000080946.42225.4D. No abstract available.

Results Reference

background

PubMed Identifier

16412870

Citation

Chow BJ, Beanlands RS, Lee A, DaSilva JN, deKemp RA, Alkahtani A, Ruddy TD. Treadmill exercise produces larger perfusion defects than dipyridamole stress N-13 ammonia positron emission tomography. J Am Coll Cardiol. 2006 Jan 17;47(2):411-6. doi: 10.1016/j.jacc.2005.09.027.

Results Reference

background

PubMed Identifier

17314342

Citation

Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007 Feb 22;356(8):830-40. doi: 10.1056/NEJMra061889. No abstract available.

Results Reference

background

PubMed Identifier

16085581

Citation

El Fakhri G, Sitek A, Guerin B, Kijewski MF, Di Carli MF, Moore SC. Quantitative dynamic cardiac 82Rb PET using generalized factor and compartment analyses. J Nucl Med. 2005 Aug;46(8):1264-71.

Results Reference

background

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Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET

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