NCT04973410Completed
The Association Between Catheter-based Coronary Flow and Resistance and 15O-H2O Positron Emission Tomography Scan
FLOW 3 - The Association Between Catheter-based Coronary Flow and Resistance and 15O-H2O Positron Emission Tomography Scan-based Absolute Myocardial Blood Flow in the Coronary Artery Territory.
Source: ClinicalTrials.gov · Last updated 31 Jul 2024
Brief summary (registry, in English)
Aims 1. To assess the correlation between absolute flow and resistance assessed by catheter-based thermodilution technique using CoroFlow®-system and myocardial blood flow (MBF) measured by positron emission tomography (PET) and the tracer \[15O\] labeled water (\[15O\]H2O) (15O-H2O PET) 2. To assess the correlation between impaired MBF measured with 15O-H2O PET and negative fractional flow reserve (FFR) and index of microvascular resistance (IMR) level. Hypothesis: In patients with angina pectoris and reduced MBF measured with 15O-H2O PET but no hemodynamic significant stenosis (FFR \> 0.80), the IMR is \>25 measured with continuous thermodilution indicating microcirculatory dysfunction. Methods: We include patients with angina pectoris and suspected coronary disease based on a cardiac-computerised tomography (CT) scan. Patients are then referred to an 15O-H2O PET (rest and stress) and then a diagnostic invasive coronary angiography (ICA) with physiological assessment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 17 Mar 2021
- Start date
- 1 Dec 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Aarhus University Hospital Skejby
- Diseases
- Coronary artery disease
- NCT number
- NCT04973410
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 1 Dec 2019 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- PCI, CABG, POBA or already acknowledge ischemic heart disease
- Acute coronary disease or AMI
- Contraindications to adenosine (severe asthma, complicated AV block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases).
- Allergy to X-ray contrast agents or severe metabolic disease.
- Donor heart, mechanical heart, or mechanical heart pump
Lab values
- Renal impairment with estimated glomerular filtration rate (eGFR) \<40 ml / min.
Other
- COPD or Asthma
- Pregnancy and breast breeding
Who the study is looking for
- Patients referred to diagnostic ICA after heart-CT
- Able to provide an informed consent.
- Age ≥ 18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.