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Comprehensive Evaluation of Ischemic Heart Disease Using MRI

Primary Purpose

Heart Disease, Ischemic, Atherosclerosis, Coronary

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gadolinium
Adenosine
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Disease, Ischemic focused on measuring Myocardial Perfusion Imaging, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

  1. Age <18 years;
  2. Known contraindication to MR imaging (such as pacemaker placement, magnetic implants, etc);
  3. Claustrophobia;
  4. Inability to perform an adequate breath-hold for imaging,
  5. Inability to provide informed consent;
  6. 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;
  7. Pregnant and lactating women;
  8. Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine, or nitroglycerin;

  9. Contra indication for Adenosine

    1. 2nd- or 3rd-degree atrioventricular block (except in patients with a functioning artificial pacemaker)

    2. Sinus node disease (except in patients with a functioning artificial

      pacemaker)

    3. Unstable angina
    4. Acute myocardial infarction

    5. Known or suspected bronchoconstrictive or bronchospastic lung

      disease (e.g., asthma)

    6. Hypersensitivity to adenosine
    7. Caffeine within 12-24 hours
    8. Theophylline and Dipyridamole products within 24 hours.

  10. Contra indication for Metoprolol

    1. sinus bradycardia
    2. heart block greater than first degree
    3. Cardiac Failure
    4. Bronchospastic Disease

  11. Contra indication for Nitroglycerin

    1. Early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin.

b .Administration of Nitrostat (nitroglycerin tablets, USP) is contraindicated in patients who are using Viagra® since Viagra has been shown to potentiate the hypotensive effects of organic nitrates.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ischemic heart disease patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol
Adverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study.

Full Information

First Posted
October 5, 2010
Last Updated
September 25, 2014
Sponsor
Northwestern University
Collaborators
Astellas Pharma US, Inc., Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01234870
Brief Title
Comprehensive Evaluation of Ischemic Heart Disease Using MRI
Official Title
Comprehensive Evaluation of Ischemic Heart Disease Using MRI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Astellas Pharma US, Inc., Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Coronary heart disease is the leading cause of death and disability in the US, accounting for about one-third of all deaths in subjects over age 35. With the development of newer Magnetic Resonance Imaging (MRI) techniques, such as faster pulse sequences and parallel imaging, cardiac MRI has become a routine tool for the evaluation and detection of myocardial ischemic disease. First pass myocardial perfusion (FPMP) using MRI is increasingly being used to assess ischemic heart disease. MRI offers the advantages of spatial resolution sufficient to differentiate between subendocardial and subepicardial perfusion; shorter examination time and also lack of ionizing radiation. Left ventricle cine gradient echo imaging can be used to assess regional ventricular function. Left ventricular myocardial viability can also be easily assessed at the same time in order to determine the amount of viable left ventricular myocardium and the percentage of irreversibly scarred myocardium by delayed enhanced images. Viability imaging is usually added to the perfusion protocol to increase specificity by allowing detection of fixed perfusion defects, which represent scar. The ultimate cardiac MRI protocol would be to combine both of these imaging strategies with a reliable and accurate coronary Magnetic Resonance Angiography(MRA) technique, such that obstructive coronary artery disease could be evaluated comprehensively at the same time. If all of these techniques can be combined together in a single study, it may be feasible to finally achieve a "one stop shop" for cardiac Magnetic Resonance Imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Ischemic, Atherosclerosis, Coronary
Keywords
Myocardial Perfusion Imaging, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ischemic heart disease patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gadolinium
Other Intervention Name(s)
Magnevist, Bayer HealthCare Pharmaceuticals
Intervention Type
Drug
Intervention Name(s)
Adenosine
Primary Outcome Measure Information:
Title
Magnetic Resonance Image Quality Rating
Description
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
Time Frame
Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol
Description
Adverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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 2nd- 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 disease (e.g., asthma) Hypersensitivity to adenosine Caffeine within 12-24 hours Theophylline and Dipyridamole products within 24 hours. Contra indication for Metoprolol sinus bradycardia heart block greater than first degree Cardiac Failure Bronchospastic Disease Contra indication for Nitroglycerin Early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin. b .Administration of Nitrostat (nitroglycerin tablets, USP) is contraindicated in patients who are using Viagra® since Viagra has been shown to potentiate the hypotensive effects of organic nitrates.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James C Carr, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Comprehensive Evaluation of Ischemic Heart Disease Using MRI

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