Whole-Heart Myocardial Blood Flow Quantification Using MRI

NCT03064295 | Unknown FDA Device

• 2 other identifiers: 429721R01HL124649
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease; Coronary Microvascular Disease

Outcome Measures

Primary Outcomes (2)

• CAD findings by MRI

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

  Day One

• CMD findings by MRI

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

  Day One

Study Arms (3)

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

Device: Myocardial Perfusion Cardiac MRI.; Drug: Contrast; Drug: 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.

Device: Myocardial Perfusion Cardiac MRI.; Drug: Contrast; Drug: 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.

Device: Myocardial Perfusion Cardiac MRI.; Drug: Contrast; Drug: Pharmacologic Stress Agent

Interventions

Myocardial Perfusion Cardiac MRI. DEVICE

MRI with administration of a contrast drug and a stress agent, if no contraindications are present. The gadolinium based contrast agent to be used in this study is either Gadavist (up to 0.2 mL/kg body weight (0.2 mmol/kg) or MultiHance (0.2 mmol/kg) The IV stress agent is regadenoson (0.4mg/5ml bolus) or adenosine (dosage based on subject's weight and is set at 140mcg/kg/min

Also known as: Myocardial Perfusion imaging, Myocardial Perfusion CMR, Magnetic Resonance Imaging, First Pass Myocardial Perfusion Imaging

CAD Patients; CMD Patients; Healthy Volunteers

Contrast DRUG

The intravenous gadolinium based contrast agent to be used in this study is either Gadavist (up to 0.2 mL/kg body weight (0.2 mmol/kg) or MultiHance (0.2 mmol/kg)

Also known as: contrast media, Gadavist, MultiHance

CAD Patients; CMD Patients; Healthy Volunteers

Pharmacologic Stress Agent DRUG

The stress agent administered intravenously is regadenoson (0.4mg/5ml bolus) or adenosine (dosage based on subject's weight and is set at 140mcg/kg/min

Also known as: regadenoson, adenosine, stress agent

CAD Patients; CMD Patients; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: CMD cohort will enroll female participants only.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 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).

You may qualify if:

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

You may not qualify if:

• 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;
• contraindication to stress agent (adenosine) including asthma or prior adverse reaction to adenosine
• contraindications for gadolinium contrast;

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Microvascular Angina

Interventions

Myocardial Perfusion Imaging; Magnetic Resonance Imaging; Contrast Media; gadobutrol; gadobenic acid; regadenoson; Adenosine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Perfusion Imaging; Radionuclide Imaging; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Radioisotope; Tomography; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Zhaoyang Fan, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Kim, MPH

CONTACT

310 248-8668; johanna.kim@cshs.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Biomedical Imaging Research Institute

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 27, 2017
• Study Start: March 1, 2018
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)