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Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

This study is currently recruiting participants.
Verified January 2013 by University of Cincinnati
Sponsor:
Information provided by (Responsible Party):
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01719016
First received: October 29, 2012
Last updated: January 13, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition Intervention
Coronary Artery Disease
 Procedure: Cardiac PET scan, Coronary catheterization

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Quantification of relative contributions of large artery disease and microvascular disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Correlation Coronary Flow Reserve (CFR) from Positron Emission Tomography (PET)imaging with diagnostic parameters, Pressure Drop Coefficient (CDP) and Lesion Flow Coefficient (LFC).


Secondary Outcome Measures:
  • Quantification of relative contributions of large artery disease and microvascular disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Correlation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values.


Estimated Enrollment: 80
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cardiac PET scan, 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.
 Procedure: Cardiac PET scan, 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chest pain and suspected ischemia that needs to be assessed by a stress test

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719016

Contacts
Contact: Rupak K Banerjee 5135562124 rupak.banerjee@uc.edu

Locations
United States, Ohio
Cincinnati Veteran Affairs Medical Center Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Stephanie Zazycki     513-861-3100 ext 4080     stephanie.zazycki@va.gov    
Principal Investigator: Rupak K Banerjee, PhD            
Sponsors and Collaborators
University of Cincinnati
Investigators
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: Kranthi K Kolli, MS University of Cincinnati
Principal Investigator: Srikara Viswanath Peelukhana, MS University of Cincinnati
Principal Investigator: Hanan Kerr, MD University of Cincinnati
Principal Investigator: Mariono Fernandez-Ulloa, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT01719016     History of Changes
Other Study ID Numbers: 10-05-05-02
Study First Received: October 29, 2012
Last Updated: January 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Reversible ischemia
microvascular dysfunction

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013