Phase 3 N=40 Diagnostic

Comprehensive Evaluation of Ischemic Heart Disease Using MRI

Heart Disease, Ischemic · Atherosclerosis, Coronary

Bottom Line

View on ClinicalTrials.gov: NCT01234870 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Magnetic Resonance Image Quality Rating — 3.57; 2.55 units on a likert scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Gadolinium (Drug); Adenosine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Magnetic Resonance Image Quality Rating	3.57; 2.55	<0.001 sig
SECONDARY Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol	—	—

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.

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01234870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.