Phase 2 N=20 Single-blind Diagnostic

Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI

Myocardial Ischemia

Bottom Line

View on ClinicalTrials.gov: NCT01655043 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: Primary: Quantification of Myocardial Blood Volume — 3.63; 1.23 seconds^-1

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Regadenoson (Drug); gadofoveset trisodium (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Quantification of Myocardial Blood Volume	3.63; 1.23	—

Summary

Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery disease that is considered most accurate is coronary angiography however it involves risk and radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi qualitative analysis of the myocardial perfusion images. In this proposal the investigators will develop a means to calculate Coronary Flow Reserve (CFR) using the MRI. the investigators approach has the potential to reduce mortality from myocardial infarction by effecting a change in the patient management paradigm. Absolute quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with more accuracy than the semi-quantitative or qualitative analysis of perfusion images. Measurement of Coronary Flow Reserve is important for the following reasons: decrease of coronary flow reserve has been identified as a first effect of CAD; it provides an objective measure of treatment efficacy. The purpose of this study is to compare images from nuclear stress test and/or coronary angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary artery disease calculating myocardial blood flow using a novel MRI technique combined to an extracellular Gadolinium-based contrast agent and stressor agent

Eligibility Criteria

Inclusion Criteria

Under an Institutional Committee on Human Research board approved protocol, 20 patients with a suspected myocardial ischemic disease with positive stress nuclear medicine test laboratory will be recruited in this prospective study. All subjects will be screened for GFR within 24 hours before the exam. All patients must have a GFR > 30 mL/min/1.73m2 to be included in 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 < 30mL/min will not be selected for the study to avoid NSF.

Exclusion Criteria

Age 18 to 89 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 < 60 ml/min will be excluded;
Pregnant and lactating women;
Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine, or nitroglycerin;
Contra indication for Regadenoson
2nd- or 3rd-degree AV 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01655043). 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.