Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myocardial Perfusion Imaging by 15O-H2O PET/CT

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451551
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

The trial will include 1000 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. The patients will undergo the clinical scan as normal.

Data from the scans will be used to determine reference values of the examination.

Follow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.


Condition or disease
Ischemic Heart Disease

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Myocardial Perfusion Imaging by 15O-H2O PET/CT: Reference Values and Prognostic Value
Estimated Study Start Date : June 23, 2020
Estimated Primary Completion Date : June 23, 2030
Estimated Study Completion Date : June 23, 2030



Primary Outcome Measures :
  1. Prognostic value [ Time Frame: 10 years ]
    Number of participants who experience a major adverse cardiac event within 10 years of follow-up.


Secondary Outcome Measures :
  1. Myocardial blood flow [ Time Frame: 5 Years ]
    The myocardial blood flow of participants assessed by 15O-H2O PET/CT

  2. Coronary flow reserve [ Time Frame: 5 Years ]
    The coronary flow reserve of participants assessed by 15O-H2O PET/CT

  3. Pulmonary transit time [ Time Frame: 5 Years ]
    The pulmonary transit time of participants assessed by 15O-H2O PET/CT

  4. Left ventricular end-systolic volume [ Time Frame: 5 Years ]
    The left ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT

  5. Left ventricular end-diastolic volume [ Time Frame: 5 Years ]
    The left ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT

  6. Right ventricular end-systolic volume [ Time Frame: 5 Years ]
    The right ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT

  7. Right ventricular end-diastolic volume [ Time Frame: 5 Years ]
    The right ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient with known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, not meeting any exclusion criteria will be enrolled in the study.
Criteria

Inclusion Criteria:

  • Known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital

Exclusion Criteria:

  • Claustrophobia, severe asthma, younger than 18 years
Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04451551    
Other Study ID Numbers: 15O-H2O PET Cohort
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Myocardial Perfusion Imaging
Positron-Emission Tomography
Coronary Artery Disease
Coronary Flow Reserve
Myocardial Blood Flow
Prognosis
Reference Value
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases