Whole-Heart Myocardial Blood Flow Quantification Using MRI

Coronary Artery Disease Clinical Trial

Official title:

Whole-Heart Myocardial Blood Flow Quantification Using Magnetic Resonance Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03064295
• Other study ID #: 42972
• Secondary ID: 1R01HL124649
• Status: Recruiting
• Start date: March 1, 2018
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2023
• Source: Cedars-Sinai Medical Center
• Contact: Johanna Kim, MPH
• Phone: 310 248-8668
• Email: johanna.kim[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Microvascular Disease
• Microvascular Angina

Intervention

Device:
• 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

Drug:
• 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)
• 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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAD findings by MRI	Accuracy (sensitivity and specificity) of MRI-based diagnosis of coronary artery disease (CAD) as compared to PET.	Day One
Primary	CMD findings by MRI	Accuracy (sensitivity and specificity) of MRI-based diagnosis of coronary microvascular dysfunction (CMD), as compared to CRT.	Day One