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Recruiting NCT04451551

Myocardial Perfusion Imaging by 15O-H2O PET/CT

Observational Ischemic Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ischemic Heart Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Myocardial Perfusion Imaging by 15O-H2O PET/CT: Reference Values and Prognostic Value

Overview

The trial will include 5000 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.

Primary outcome measures

  • Prognostic value within 10 years [Time frame: 10 years]
Secondary outcome measures (12)
  • Myocardial blood flow [Time frame: 5 Years]
  • Coronary flow reserve [Time frame: 5 Years]
  • Pulmonary transit time [Time frame: 5 Years]
  • Left ventricular end-systolic volume [Time frame: 5 Years]
  • Left ventricular end-diastolic volume [Time frame: 5 Years]
  • Right ventricular end-systolic volume [Time frame: 5 Years]
  • Right ventricular end-diastolic volume [Time frame: 5 Years]
  • Immediate coronary angiography followup [Time frame: 5 years]
  • Immediate percutaneous coronary intervention (PCI) followup [Time frame: 5 years]
  • Immediate coronary artery bypass graft (CABG) followup [Time frame: 5 years]
  • Prognostic value within 5 years [Time frame: 5 years]
  • Prognostic value within 2 years [Time frame: 2 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Aarhus University Hospital — Aarhus

Identifiers

NCT: NCT04451551 · 15O-H2O PET Cohort

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗