Whole-Heart Myocardial Blood Flow Quantification Using MRI

NCT ID: NCT03064295

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2025-01-01

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.

Conditions

Coronary Artery Disease; Coronary Microvascular Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Myocardial Perfusion Cardiac MRI.

Intervention Type: 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

Contrast

Intervention Type: 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)

Pharmacologic Stress Agent

Intervention Type: 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

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.

Myocardial Perfusion Cardiac MRI.

Intervention Type: 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

Contrast

Intervention Type: 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)

Pharmacologic Stress Agent

Intervention Type: 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

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.

Myocardial Perfusion Cardiac MRI.

Intervention Type: 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

Contrast

Intervention Type: 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)

Pharmacologic Stress Agent

Intervention Type: 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

Interventions

Myocardial Perfusion Cardiac MRI.

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

Intervention Type: DEVICE

Contrast

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)

Intervention Type: DRUG

Pharmacologic Stress Agent

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

Intervention Type: DRUG

Other Intervention Names

Myocardial Perfusion imaging; Myocardial Perfusion CMR; Magnetic Resonance Imaging; First Pass Myocardial Perfusion Imaging; contrast media; Gadavist; MultiHance; regadenoson; adenosine; stress agent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Debiao Li, PhD

Director, Biomedical Imaging Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhaoyang Fan, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Johanna Kim, MPH

Role: CONTACT

johanna.kim@cshs.org

310 248-8668

Other Identifiers

1R01HL124649

Identifier Type: NIH

Identifier Source: secondary_id

View Link

42972

Identifier Type: -

Identifier Source: org_study_id