Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Brigham and Women's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sharmila Dorbala, MBBS, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01109992
First received: April 16, 2010
Last updated: July 10, 2013
Last verified: September 2012
  Purpose

This is a single-center study of subjects undergoing clinically indicated heart scans for evaluation of known or suspected 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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Exercise plus Regadenoson (Lexercise)
Drug: Regadenoson (Lexiscan)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Integrated Dual Exercise and Lexiscan PET: IDEAL PET

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Safety and tolerability of combined exercise and regadenoson stress [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

    Safety and tolerability of combined standard Bruce exercise stress testing combined with regadenoson infusion will be studied.

    • Side effects, ECG changes, blood pressure changes, will be recorded during Lexercise and compared to Lexiscan study.
    • Safety blood work will be drawn after the Lexercise PET study.
    • 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 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

    Image quality: The following parameters will be measured in the Lexiscan study and compared to the Lexercise study

    • Motion artifacts
    • Image registration
    • Sub diaphragmatic activity (liver heart ratios)
    • Defect contrast
    • Signal to noise ratio and
    • Dynamic image evaluability will be assessed

  • Diagnostic Value [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    • Defect size, severity, extent and contrast with Lexiscan alone will be compared to exercise Lexiscan protocol
    • Left ventricular ejection fraction at rest and immediately post stress with Lexiscan alone will be compared to the Lexercise protocol.
    • Myocardial blood flow estimates and coronary flow reserve will be compared between the Lexiscan alone and Lexercise protocols.
    • Comparison to coronary angiography results when available.


Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Regadenoson (Lexiscan)
Regadenoson Rubidium-82 Positron Emission Tomography
Drug: Regadenoson (Lexiscan)
Regadenoson Rubidium-82 Positron Emission Tomography
Experimental: Exercise + Regadenoson (Lexiscan)
Exercise plus Regadenoson (Lexiscan) 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Clinically indicated N-13 ammonia PET study
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109992

Contacts
Contact: Sharmila Dorbala, MBBS 857-307-2000 sdorbala@partners.org
Contact: Divya Vangala, MA 617-732-6290 dvangala@partners.org

Locations
United States, Massachusetts
Brigham and Womens' Hospital Recruiting
Boston, Massachusetts, United States, 02421
Contact: Divya Vangala       dvangala@partners.org   
Principal Investigator: Sharmila Dorbala, MBBD, MPH         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Sharmila Dorbala Brigham and Women's Hospital
  More Information

Publications:
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. No abstract available.

Responsible Party: Sharmila Dorbala, MBBS, Director, Nuclear Cardiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01109992     History of Changes
Other Study ID Numbers: BWH
Study First Received: April 16, 2010
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
coronary artery disease
exercise
regadenoson
positron emission tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Agonists
Purinergic P1 Receptor Agonists

ClinicalTrials.gov processed this record on October 20, 2014