Myocardial Mass Determination by FFRct and Absolute Coronary Blood Flow

NCT03393871 | Completed DMC FDA Device

• 1 other identifier: MyoMass
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Comparison of Mass and flow

  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

  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

Interventions

absolute blood flow measurement DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Nico HJ Pijls, MD, PhD

  Catharina Ziekenhuis Eindhoven

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. PHD

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 9, 2018
• Study Start: February 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: July 24, 2019

Record last verified: 2018-02

Locations

NL (1)