NCT03393871

Myocardial Mass Determination by FFRct and Absolute Coronary Blood Flow

Myocardial Mass Determination of the Different Coronary Territories by FFRct and Invasive Measurement of Absolute Coronary Blood Flow. A Clinical Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Catharina Ziekenhuis Eindhoven · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The background for performing the present study is to compare the mass calculations by CT scanning and by invasive absolute blood flow measurements and thereby corroborating both methods.

Detailed description

Although knowledge about the myocardial mass (in grams) of the different territories belonging to the major coronary arteries, is of clinical importance to estimate risk of coronary interventions (PCI, CABG) and to determine area of necrosis after myocardial infarction, no invasive methodology has been available so far for reliable assessment of mass. Especially in the setting of percutaneous coronary intervention (PCI), it would be valuable to have information about the absolute and relative myocardial mass distal to the location where the intervention is planned. Such information is valuable for risk estimation and can also be helpful in multivessel disease to determine the most adequate way of revascularization. Both MRI and CT scanning have claimed to be able to estimate myocardial mass non-invasively, but by the lack of any gold standard, none of these methods could be validated in vivo so far. A relatively new development in CT technology is the calculation of fractional flow reserve (FFR) by CT scanning, according to a sophisticated algorithm developed by Heartflow Inc. One of the baseline assumptions in that algorithm is that myocardial mass is proportional to resting blood flow, which seems a plausible assumption from a rational physiological point of view. More recently, invasive calculation of absolute blood flow has become possible as well as resistance measurement of the (microcirculation of the) myocardium. Using that invasive technology (explained in the appendix to this protocol), it can be assumed that measuring absolute maximum blood flow in a coronary artery as well as fractional flow reserve for different territories or for different spots within one major coronary artery, provides a basis for relative mass calculation. The background for performing the present study is to compare these mass calculations by CT scanning and by invasive measurements, thereby corroborating both methods.

Conditions

• Fractional Flow Reserve
• Absolute Flow Measurement
• FFR-CT
• Myocardial Mass
• Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	absolute blood flow measurement	Absolute maximum flow will be measured, using the RayFlow® multifunctional monorail infusion catheter. (This measurement takes a few minutes per artery, does not require any additional drug, but only 50-100 ml of saline per artery, and is not associated with any additional risk for the patient compared to the regular invasive procedure.

Timeline

• Start date: 2018-02-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2018-01-09
• Last updated: 2019-07-24

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated device study