Comprehensive Evaluation of Ischemic Heart Disease Using MRI

NCT01234870 | Completed Phase 2 Results DMC

• 2 other identifiers: CR1_STU00006013ASCA-9J02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the diagnostic performance of fully automated motion corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart disease, using coronary angiography as the reference standard. It is expected that this improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary artery disease and may obviate the need for other more expensive and invasive diagnostic tests currently used.

Conditions

Heart Disease, Ischemic; Atherosclerosis, Coronary

Keywords

Myocardial Perfusion Imaging; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Magnetic Resonance Image Quality Rating

  The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality

  Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.

Secondary Outcomes (1)

• Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol

  14 days

Study Arms (1)

Ischemic heart disease patients

EXPERIMENTAL

Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.

Drug: Gadolinium; Drug: Adenosine

Interventions

Gadolinium DRUG

Also known as: Magnevist, Bayer HealthCare Pharmaceuticals

Ischemic heart disease patients

Adenosine DRUG

Ischemic heart disease patients

Eligibility Criteria

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

You may qualify if:

• Under an Institutional Committee on Human Research board approved protocol 80 patients with a suspected myocardial ischemic disease recruited from the cardiac cath laboratory will be recruited in this prospective study. Volunteers will be recruited for the purpose of protocol development and will not be included in analysis. All subjects will be screened for glomerular filtration rate (GFR) within 24 hours before the exam. All patients must have a GFR \> 30 mL/min/1.73m2 to be part of the study.
• All subjects will be selected following the Nephrogenic Systemic Fibrosis (NSF) guidelines. All dialysis patients or end-stage renal disease patients with a creatinine clearance of \< 30 mL/min will not be selected for the study to avoid NSF. Patients with GFR \< 60 ml/min but \>30 ml/min will receive a reduced dose of Gadolinium contrast (0.1 ml/kg).

You may not qualify if:

• Age \<18 years;
• Known contraindication to MR imaging (such as pacemaker placement, magnetic implants, etc);
• Claustrophobia;
• Inability to perform an adequate breath-hold for imaging,
• Inability to provide informed consent;
• all subjects will be will be screened for GFR within 24 hours before the exam and subjects presenting with GFR \< 30 ml/min will be excluded;
• Pregnant and lactating women;
• Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine, or nitroglycerin;
• Contra indication for Adenosine
• nd- or 3rd-degree atrioventricular block (except in patients with a functioning artificial pacemaker)
• Sinus node disease (except in patients with a functioning artificial
• pacemaker)
• Unstable angina
• Acute myocardial infarction
• Known or suspected bronchoconstrictive or bronchospastic lung

Sponsors & Collaborators

• Northwestern University: lead
• Astellas Pharma US, Inc.: collaborator
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Interventions

Gadolinium; Gadolinium DTPA; Adenosine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

The small number of subjects results in reduced statistical power; The cohort was selected from patients at a single medical center, potentially reducing generalizability; Variability in patient behavior during MR scans may affect analyses

Results Point of Contact

• Title: Dr. James Carr
• Organization: Northwestern University

jcarr@northwestern.edu

(312)695-4218

Study Officials

• James C Carr, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Imaging, Department of Radiology,Associate Professor of Radiology and Medicine, Northwestern University Feinberg School of Medicine

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: November 4, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 26, 2014
• Results First Posted: September 26, 2014

Record last verified: 2014-09

Locations

US (1)