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Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01719016
First Posted: November 1, 2012
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rupak K. Banerjee, University of Cincinnati
October 29, 2012
November 1, 2012
May 15, 2017
August 2010
June 2019   (Final data collection date for primary outcome measure)
Quantification of relative contributions of large artery disease and microvascular disease [ Time Frame: 2 years ]
Correlation Coronary Flow Reserve (CFR) from Positron Emission Tomography (PET)imaging with diagnostic parameters, Pressure Drop Coefficient (CDP) and Lesion Flow Coefficient (LFC).
Same as current
Complete list of historical versions of study NCT01719016 on ClinicalTrials.gov Archive Site
Quantification of relative contributions of large artery disease and microvascular disease [ Time Frame: 2 years ]
Correlation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values.
Same as current
Not Provided
Not Provided
 
Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics
Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics
Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with pressure and flow readings, are being investigated.
Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with pressure and flow readings, are being investigated. The diagnostic parameters will be correlated with Coronary Flow Reserve (CFR)values obtained using Positron Emission Tomography (PET) imaging. They will also be correlated with Fractional Flow Reserve (FFR).
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with chest pain and suspected ischemia that needs to be assessed by a stress test
Coronary Artery Disease
Procedure: Cardiac PET, Coronary catheterization

Patients would under go a Cardiac rest and stress PET scan and include the following drug administration:

  1. N-13 Ammonia radionuclide - Two doses, 10 mCi for rest, 20 mCi for stress
  2. Lexiscan - stress agent for PET scan

Patients would also undergo Coronary catheterization including the following drug administration and device usage:

  1. Combowire to obtain pressure and flow readings on Combomap machine (Volcano Therapeutics, CA).
  2. Adenosine - stress agent during catheterization, 140 ug/Kg/min
Other Names:
  • Volcano therapeutics
  • Combomap machine
  • Adenosine
  • Lexiscan
  • N-13 Ammonia
Cardiac PET, Coronary catheterization

Cardiac PET scan:

  1. Injection of N-13 Ammonia radionuclide. 2 doses of 10 milliCuries and 20 milliCuries each.
  2. Injection of Lexiscan.

Coronary catheterization:

  1. Pressure and flow readings using Combowire
  2. Injection of Adenosine.
Intervention: Procedure: Cardiac PET, Coronary catheterization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
68
June 2019
June 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or above
  • Patients referred to a stress test by a Cardiologist
  • Acute Chest pain, as per patient input.
  • Risk Assessment with prior test results and/or previous history of known chronic stable CAD.
  • Borderline or discordant stress testing where obstructive CAD remains a concern.
  • New or worsening symptoms- Abnormal coronary angiography or abnormal prior stress imaging study.
  • Coronary stenosis or anatomic abnormality of uncertain significance.
  • In absence of reliable diagnostic information from another imaging modality.

Exclusion Criteria:

  • Left ventricular ejection fraction less the 25% determined by gated SPECT imaging
  • Non-dialysis dependent chronic kidney disease with baseline serum creatinine greater than 2.5 gm/dL.
  • History of type II heparin-induced thrombocytopenia.
  • Significant co-morbid condition that is medically unstable and would make coronary angiography prohibitive or contraindicated.
  • Pregnant women.
  • Incapacitated for Consent
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01719016
10-05-05-02
No
Not Provided
Plan to Share IPD: Undecided
Rupak K. Banerjee, University of Cincinnati
University of Cincinnati
Not Provided
Principal Investigator: Rupak K Banerjee, PhD University of Cincinnati , CVAMC
Principal Investigator: Mohamed Effat, MD Univesity of Cincinnati, University Hospital
Principal Investigator: Imran Arif, MD University of Cincinnati and University Hospital
Principal Investigator: Hanan Kerr, MD University of Cincinnati
University of Cincinnati
May 2017