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Clinical Trials/NCT03064295
NCT03064295
Recruiting
N/A

Whole-Heart Myocardial Blood Flow Quantification Using Magnetic Resonance Imaging

Cedars-Sinai Medical Center1 site in 1 country160 target enrollmentMarch 1, 2018

Overview

Phase
N/A
Intervention
Myocardial Perfusion Cardiac MRI.
Conditions
Coronary Artery Disease
Sponsor
Cedars-Sinai Medical Center
Enrollment
160
Locations
1
Primary Endpoint
CAD findings by MRI
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

This study hopes to provide significant technical improvement in a Myocardial Blood Flow (MBF) cardiac magnetic resonance (CMR) quantification technique to address challenges and technical limitations for MBF CMR. By developing and validating novel techniques to improve first-pass perfusion (FPP) cardiac MR, we propose to increase diagnostic accuracy by minimizing false positives and false negatives, allow for better evaluation and accurate quantification of total ischemic burden and reduce image and motion-induced artifacts.

The broad, long-term objective of the proposed project is to improve the prognosis of patients with myocardial ischemia caused by coronary artery disease (CAD) or coronary microvascular dysfunction (CMD).

Detailed Description

All subjects will receive cardiac MRI scans to diagnose CAD or CMD. MR perfusion scans will be performed twice per subject: once at rest, and once after administration of a pharmacologic stress agent. There will be a \>15 minute delay between the two scans. A gadolinium-based contrast agent will be administered during each scan to allow measurement of myocardial blood flow. Once myocardial blood flow is quantified, the measurements will be compared to previous reference measurements (when available) from PET myocardial perfusion imaging in the CAD patient cohort and coronary reactivity testing (CRT) in the CMD patient cohort.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
January 1, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Debiao Li, PhD

Director, Biomedical Imaging Research Institute

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

  • 60 healthy male or female (18 or older) participants
  • 110 male or female adults (18 or older) who have undergone clinical myocardial perfusion imaging at CSMC and been diagnosed with Coronary Disease (CAD).
  • 50 female adults (21 or older) who have undergone coronary reactivity testing at CSMC and been diagnosed with coronary microvascular disease (CMD).

Exclusion Criteria

  • MR imaging is contraindicated in persons with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps.
  • Persons with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
  • Patients who are pregnant, nursing, implanted with non MR-compatible intrauterine devices (IUD's)
  • Persons unable to tolerate MRI imaging secondary to an inability to lie supine or severe claustrophobia.
  • Persons who are non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions
  • Persons whose renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR \<45ml/min).
  • Persons with stated allergy to animal dander
  • acute coronary syndrome or acute myocardial infarction or ongoing myocardial ischemia or ECG evidence of ongoing ischemia;
  • patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or prior/planned PCI or CABG;
  • non-ischemic cardiomyopathy or more than moderate valvular disease;

Arms & Interventions

Healthy Volunteers

60 healthy male or female (18 or older) adults will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent

Intervention: Myocardial Perfusion Cardiac MRI.

Healthy Volunteers

60 healthy male or female (18 or older) adults will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent

Intervention: Contrast

Healthy Volunteers

60 healthy male or female (18 or older) adults will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent

Intervention: Pharmacologic Stress Agent

CAD Patients

110 male or female adults (18 or older) who have undergone clinical myocardial perfusion imaging at CSMC and been diagnosed with Coronary Disease (CAD) will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent.

Intervention: Myocardial Perfusion Cardiac MRI.

CAD Patients

110 male or female adults (18 or older) who have undergone clinical myocardial perfusion imaging at CSMC and been diagnosed with Coronary Disease (CAD) will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent.

Intervention: Contrast

CAD Patients

110 male or female adults (18 or older) who have undergone clinical myocardial perfusion imaging at CSMC and been diagnosed with Coronary Disease (CAD) will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent.

Intervention: Pharmacologic Stress Agent

CMD Patients

50 female adults (21 or older) who have undergone coronary reactivity testing at CSMC and been diagnosed with coronary microvascular disease (CMD) will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent.

Intervention: Myocardial Perfusion Cardiac MRI.

CMD Patients

50 female adults (21 or older) who have undergone coronary reactivity testing at CSMC and been diagnosed with coronary microvascular disease (CMD) will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent.

Intervention: Contrast

CMD Patients

50 female adults (21 or older) who have undergone coronary reactivity testing at CSMC and been diagnosed with coronary microvascular disease (CMD) will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent.

Intervention: Pharmacologic Stress Agent

Outcomes

Primary Outcomes

CAD findings by MRI

Time Frame: Day One

Accuracy (sensitivity and specificity) of MRI-based diagnosis of coronary artery disease (CAD) as compared to PET.

CMD findings by MRI

Time Frame: Day One

Accuracy (sensitivity and specificity) of MRI-based diagnosis of coronary microvascular dysfunction (CMD), as compared to CRT.

Study Sites (1)

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