Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01234870
Other study ID # CR1_STU00006013
Secondary ID ASCA-9J02
Status Completed
Phase Phase 2/Phase 3
First received October 5, 2010
Last updated September 25, 2014
Start date June 2010
Est. completion date January 2012

Study information

Verified date September 2014
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Drug:
Gadolinium

Adenosine


Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
Northwestern University Astellas Pharma US, Inc., Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Secondary 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. 14 days Yes
See also
  Status Clinical Trial Phase
Recruiting NCT03427996 - Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice
Not yet recruiting NCT04762472 - Air Pollution (PM2.5) on Accelerated Atherosclerosis: A Montelukast Interventional Study in Modernizing China Phase 4
Not yet recruiting NCT03174418 - Fluid-dynamics in Bifurcation PCI N/A
Not yet recruiting NCT03813017 - Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
Recruiting NCT05600088 - Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With NSTEMI or Unstable Angina N/A
Completed NCT03011775 - Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease Phase 4
Completed NCT00115583 - The Contribution of Endothelin to Vasomotor Function in Diseased Coronary Arteries N/A
Completed NCT03149042 - Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.
Not yet recruiting NCT05540223 - Safety and Clinical Performance of the DREAMS 3G Resorbable Magnesium Scaffold System N/A
Completed NCT02389946 - Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions N/A
Completed NCT03471611 - Study of Intracoronary CD34+ Cell Administration in Patients With Early Coronary Atherosclerosis Phase 1
Completed NCT00353795 - Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI) N/A
Enrolling by invitation NCT04810364 - HIV Infection And Evolvement of Atherosclerotic Plaque
Active, not recruiting NCT04175626 - Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Recruiting NCT00146887 - Comparison of Coronary CT Angiography to Invasive Coronary Angiography N/A
Completed NCT05492084 - Personalized Risk of Rapidly Progressive Atherosclerosis
Recruiting NCT04853511 - Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque Instability
Completed NCT03815032 - Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison N/A
Active, not recruiting NCT03129503 - Optical Coherence Tomography in Acute Coronary Syndrome
Recruiting NCT06393894 - Latvian Early Atherosclerosis Registry