Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET

NCT01109992 | Completed Phase 4 Results

• 1 other identifier: BWH
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; exercise; regadenoson; positron emission tomography

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Combined Exercise and Regadenoson Stress

  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 Outcomes (3)

• Image Quality: Heart to Liver Ratio of Counts

  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

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

• Peak Stress Myocardial Blood Flow

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

Study Arms (2)

Regadenoson (Lexiscan)

ACTIVE COMPARATOR

Regadenoson Rubidium-82 Positron Emission Tomography

Drug: Regadenoson (Lexiscan)

Exercise + Regadenoson (Lexercise)

EXPERIMENTAL

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

Drug: Exercise plus Regadenoson (Lexercise)

Interventions

Exercise plus Regadenoson (Lexercise) DRUG

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

Also known as: Exercise plus Lexiscan

Exercise + Regadenoson (Lexercise)

Regadenoson (Lexiscan) DRUG

Regadenoson Rubidium-82 Positron Emission Tomography

Regadenoson (Lexiscan)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Womens' Hospital

Boston, Massachusetts, 02421, United States

Location

Related Publications (6)

• 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.

  PMID: 15837254 BACKGROUND

• 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.

  PMID: 17372188 BACKGROUND

• 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.

  PMID: 12975245 BACKGROUND

• 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.

  PMID: 16412870 BACKGROUND

• 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.

  PMID: 17314342 BACKGROUND

• 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.

  PMID: 16085581 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Motor Activity

Interventions

Exercise; regadenoson

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Sharmila Dorbala
• Organization: Brigham and Women's Hospital

sdorbala@partners.org

617-732-6215

Study Officials

• Sharmila Dorbala, MBBS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Nuclear Cardiology

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 23, 2010
• Study Start: February 1, 2011
• Primary Completion: June 6, 2017
• Study Completion: June 6, 2017
• Last Updated: October 25, 2018
• Results First Posted: October 25, 2018

Record last verified: 2018-09

Locations

US (1)