Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET

Coronary Artery Disease Clinical Trial

— IDEALPET  

Official title:

Integrated Dual Exercise and Lexiscan PET: IDEAL PET

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109992
• Other study ID #: BWH
• Status: Completed
• Phase: Phase 4
• Start date: February 2011
• Est. completion date: June 6, 2017

Study information

• Verified date: September 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 6, 2017
• Est. primary completion date: June 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Exercise plus Regadenoson (Lexercise)
Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
• Regadenoson (Lexiscan)
Regadenoson Rubidium-82 Positron Emission Tomography

Locations

Country	Name	City	State
United States	Brigham and Womens' Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (6)

Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007 Feb 22;356(8):830-40. Review. — View 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. — View 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. — View Citation

Di Carli MF, Hachamovitch R. New technology for noninvasive evaluation of coronary artery disease. Circulation. 2007 Mar 20;115(11):1464-80. Review. — View Citation

El Fakhri G, Sitek A, Guérin 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day of the research scan during the stress test
Secondary	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.	Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Secondary	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.	Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Secondary	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.	Week 1 (day of the clinical scan), and Week 2 (day of the research scan)