Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET

NCT ID: NCT01109992

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2017-06-06

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Regadenoson (Lexiscan)

Regadenoson Rubidium-82 Positron Emission Tomography

Group Type: ACTIVE_COMPARATOR

Regadenoson (Lexiscan)

Intervention Type: DRUG

Regadenoson Rubidium-82 Positron Emission Tomography

Exercise + Regadenoson (Lexercise)

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

Group Type: EXPERIMENTAL

Exercise plus Regadenoson (Lexercise)

Intervention Type: DRUG

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

Interventions

Exercise plus Regadenoson (Lexercise)

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

Intervention Type: DRUG

Regadenoson (Lexiscan)

Regadenoson Rubidium-82 Positron Emission Tomography

Intervention Type: DRUG

Other Intervention Names

Exercise plus Lexiscan

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sharmila Dorbala, MBBS

Director, Nuclear Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharmila Dorbala, MBBS

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Womens' Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15837254 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17372188 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12975245 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16412870 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17314342 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16085581 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BWH

Identifier Type: -

Identifier Source: org_study_id