CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Coronary Physiology +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04973410
NCT04973410N/ACompleted

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.

Aarhus University Hospital Skejby·interventional·Posted Jul 22, 2021·Updated Jul 31, 2024

In Brief

A clinical study evaluating Coronary Physiology and 15O-H2O-PET scan for Coronary Artery Disease. Completed, enrolled 40 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 22, 2021
Enrollment StartDec 1, 2019
Primary CompletionDec 31, 2023
Study CompletionJul 1, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 4.9 years ago

Interventions

Coronary Physiologyother

Invasive coronary physiology measurements during diagnostic CAG with thermodilution method with the CoroFlow® (Coroventis, Uppsala, Sweden)

15O-H2O-PET scanother

Myocardial blood flow (MBF) measured with oxygen-15 (O-15) labelled water used as a tracer molecule with positron emission tomography (PET)