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The Association Between Catheter-based Coronary Flow and Resistance and 15O-H2O Positron Emission Tomography Scan

NCT04973410 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-31

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Coronary Physiology

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

DIAGNOSTIC_TEST

15O-H2O-PET scan

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

Sponsors & Collaborators

  • Aarhus University Hospital Skejby

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2023-12-31
Completion
2024-07-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04973410 on ClinicalTrials.gov