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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

April 16, 2010
July 10, 2013
February 2011
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01109992 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET
Integrated Dual Exercise and Lexiscan PET: IDEAL PET

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
  • Drug: Exercise plus Regadenoson (Lexercise)
    Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
  • Drug: Regadenoson (Lexiscan)
    Regadenoson Rubidium-82 Positron Emission Tomography
  • Active Comparator: Regadenoson (Lexiscan)
    Regadenoson Rubidium-82 Positron Emission Tomography
    Intervention: Drug: Regadenoson (Lexiscan)
  • Experimental: Exercise + Regadenoson (Lexiscan)
    Exercise plus Regadenoson (Lexiscan) Rubidium-82 Positron Emission Tomography
    Intervention: Drug: Exercise plus Regadenoson (Lexercise)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Sharmila Dorbala, MBBS 857-307-2000 sdorbala@partners.org
Contact: Divya Vangala, MA 617-732-6290 dvangala@partners.org
United States
 
NCT01109992
BWH
No
Sharmila Dorbala, MBBS, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Sharmila Dorbala Brigham and Women's Hospital
Brigham and Women's Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP