Recruiting

Myocardial Blood Flow

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT03064295

Conditions

Coronary Artery Disease

Coronary Microvascular Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Myocardial Perfusion Cardiac MRI.

Contrast

Pharmacologic Stress Agent

Study Details

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

Study ID

NCT03064295

Start date

Mar 1, 2018

Status verified date

Feb, 2023

Completion date

Jan 1, 2025

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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;

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

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.

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

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

Primary outcome measure

  • CAD findings by MRI [ Time Frame: Day One ]
  • CMD findings by MRI [ Time Frame: Day One ]

Central Contacts and Locations

Central contacts

Johanna Kim, MPH

310 248-8668johanna.kim@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Zhaoyang Fan, PhD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2023-02-08.