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11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01917136
Recruitment Status : Completed
First Posted : August 6, 2013
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
Brigham and Women's Hospital
University of Maryland
Yale University
Washington University School of Medicine
The Cardiovascular Medical Research and Education Fund
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE August 3, 2013
First Posted Date  ICMJE August 6, 2013
Results First Submitted Date  ICMJE November 30, 2018
Results First Posted Date  ICMJE February 5, 2019
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE August 2013
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
Changes in RV Function [ Time Frame: 6 months ]
RV function as measured by cardiac MRI
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2013)
  • Myocardial oxygen consumption, FDG uptake, and myocardial perfusion [ Time Frame: baseline ]
    Compare Myocardial oxygen consumption, FDG uptake, and myocardial perfusion at baseline for subjects with near normal right ventricular function and those with persistent right ventricular dysfunction
  • Myocardial oxygen consumption and FDG uptake and myocardial perfusion [ Time Frame: 6 months ]
    Assess change from baseline in Myocardial oxygen consumption and FDG uptake and myocardial perfusion in subjects with persistent right ventricular dysfunction who are treated with ranolazine or placebo
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2013)
Changes in myocardial structure and function [ Time Frame: 6 months ]
Using CMR, comparing myocardial structure and function in patients treated with ranolazine or placebo
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
Official Title  ICMJE Evaluation of Regional Myocardial Perfusion, Glucose Utilization and Oxidative Metabolism in Patients With Pulmonary Hypertension Using Combined [11C]Acetate and [18F]Fluorodeoxyglucose (FDG) PET/CT and Cardiovascular MRI
Brief Summary This study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction.
Detailed Description

We will measure right ventricular metabolic and structural changes using serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment with ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for normal function patients). This is a companion imaging trial for patients who are eligible for the treatment trial entitled "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction". Subjects must enroll in companion treatment protocol to qualify for the imaging protocol.

The cardiac MRI portion of the study continued, but the PET portion of the study was discontinued due to funding.

The treatment protocol is registered under: NCT01839110. Due to funding issues, the completed study was registered under NCT02829034.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE
  • Drug: 11C-acetate
    For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate
  • Drug: [18F]Fluoro-2-deoxy-2-D-glucose
    For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG
    Other Name: 18F-FDG
  • Other: Cardiac MRI
    Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.
Study Arms  ICMJE Experimental: 11c-acetate and 18F-FDG, and cardiac MRI
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed.
Interventions:
  • Drug: 11C-acetate
  • Drug: [18F]Fluoro-2-deoxy-2-D-glucose
  • Other: Cardiac MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2019)
21
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2013)
54
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Participation in the companion treatment protocol "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction"

Exclusion Criteria:

  • Pregnancy or lactation: Women of childbearing potential must have a negative urine or blood pregnancy test on the day of the PET/CT scan.
  • Severe anxiety or claustrophobia prohibiting completion of imaging
  • Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET)
  • Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI.
  • Uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01917136
Other Study ID Numbers  ICMJE 817786
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Data available upon request
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • University of Maryland
  • Yale University
  • Washington University School of Medicine
  • The Cardiovascular Medical Research and Education Fund
Investigators  ICMJE
Principal Investigator: Yuchi Han, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date November 2018

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