Clinical Trials Logo
  1. Home
  2. Ischemic Heart Disease
  3. NCT04594941

A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes

Ischemic Heart Disease Clinical Trial

Official title:
A Descriptive, Comparative, Randomized, Crossover Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion Imaging Quality Using High Performance Liquid Chromatography (HPLC) and Solid Phase Extraction (SPE) Manufacturing Processes

Clinical Trial Summary

This was a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in participants referred for evaluation of known coronary artery disease (CAD) or for suspected CAD with intermediate to high pre-test probability (PTP). The objective is to assess the difference and variability between 2 sets of rest images synthesized by the same or 2 different manufacturing processes. Twenty-eight evaluable [participants were enrolled in this study and underwent 2 Flurpiridaz (18F) Injection PET-MPI at rest. Each participant attended a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz (18F) Injection PET-MPI. The participants were randomized 1:1:1:1 to 4 possible sequences of receiving 2 doses of Flurpiridaz (18F) Injection: 2 groups of 7 participants received 2 Flurpiridaz (18F) Injection doses synthesized by the same manufacturing processes (either HPLC or SPE) and 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses synthesized by different manufacturing processes (1 dose by HPLC followed by 1 dose by SPE or 1 dose by SPE followed by 1 dose by HPLC). All participants were followed up by telephone for adverse events (AEs) and serious AEs (SAEs) at 24 (+8) hours following each Flurpiridaz (18F) Injection administration.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04594941
Study type Interventional
Source GE Healthcare
Contact
Status Completed
Phase Phase 2
Start date January 27, 2022
Completion date May 26, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Active, not recruiting NCT04562805 - Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT) N/A
Recruiting NCT05292079 - CAPTURER PMCF Study ( rEPIC04D )
Recruiting NCT05292092 - Essential Pro PMCF Study ( rEPIC04E )
Recruiting NCT05292118 - Navitian PMCF Study ( rEPIC04C )
Recruiting NCT05292014 - ANGIOLITE PMCF Study ( rEPIC04F )
Completed NCT05292105 - NC Xperience PMCF Study( rEPIC04B)
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Not yet recruiting NCT04153383 - Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
Recruiting NCT02729064 - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose Phase 1
Recruiting NCT02982434 - The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation Phase 2
Completed NCT02468401 - Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions N/A
Completed NCT02759406 - Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study N/A
Recruiting NCT01681381 - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization N/A
Completed NCT01604213 - Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease Phase 4
Completed NCT01699802 - Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa) N/A
Completed NCT01334268 - RESOLUTE China RCT N/A
Completed NCT01724567 - Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training N/A
Completed NCT02159235 - Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD) N/A