Myocardial Mass Determination by FFRct and Absolute Coronary Blood Flow (MyoMass)

July 23, 2019 updated by: Nico Pijls, Catharina Ziekenhuis Eindhoven

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Brabant
      • Eindhoven, Brabant, Netherlands, 5623EJ
        • Catharina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sixty patients will be included who are scheduled

  1. Either for multivessel FFR/PCI fulfilling the following criteria and not meeting any of the exclusion criteria (prospective group)
  2. Or patients in whom both coronary CT scanning and invasive exams have been performed already for clinical reasons and of whom "complete data" are available already (retrospective group)

Description

Inclusion Criteria:

  • Presence of multivessel coronary disease with an indication for multivessel FFR and/or PCI or patients with single vessel disease scheduled for FFR/PCI of that single coronary artery
  • Availability of a coronary CT scan performed prior to the scheduled invasive investigation. The time difference between the CT scan and the invasive exam should be less than 3 months.
  • Focal lesions only
  • Normal left ventricular function
  • Age < 75 years
  • Note: previous uncomplicated PCI in any of the coronary arteries is permitted

Exclusion Criteria:

  • Inability to give informed consent
  • Diffuse coronary disease
  • Tortuous or calcified arteries interfering with reliable invasive FFR assessment
  • Previous myocardial infarction or ejection fraction less than 60% by echocardiography or ventriculography or less than 50% by nuclear methods
  • Atrial fibrillation interfering with high quality coronary CT scanning
  • Contra-indications for CT scanning
  • Left main stenosis
  • Age > 75 years
  • Pregnancy or desired pregnancy in the future

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Mass and flow
Time Frame: 3 months
To compare relative myocardial mass distribution (i.e. mass of the respective territories of LAD, LCX and RCA) by CT scanning to normalized hyperemic blood flow in the three major myocardial territories as assessed by absolute flow measurements and FFR in patients with an indication for multivessel FFR measurement.
3 months
Comparison of Mass and flow in the LAD
Time Frame: 3 months
To compare relative myocardial mass belonging to a proximal or a mid segment of one of the major coronary arteries measured by CT scanning to invasive absolute flow and FFR measurement in that particular proximal or mid coronary artery in patients undergoing single or multivessel PCI.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Nico HJ Pijls, MD, PhD, Catharina Ziekenhuis Eindhoven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

December 28, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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