Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance

June 7, 2022 updated by: Martin Ugander, Karolinska Institutet
The purpose of this study is to validate a full-automated post-processing software for quantitative perfusion of the myocardium with magnetic resonance imaging.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiac magnetic resonance (CMR) imaging is a wide available technique for the diagnosis of myocardial ischemia. However, myocardial first-pass perfusion evaluation has been limited due to the moderate accuracy of the currently available qualitative and semiquantitative methods used to assess myocardial perfusion, and due to the lack of efficient absolute quantitative methods. Some CMR techniques and post-processing mathematical models have been developed for quantitative measurement of myocardial blood flow reserve with perfusion CMR under pharmacological stress. Measurement of these parameters with CMR have been shown to increase the accuracy of CMR in diagnosing myocardial ischemia, but most of these methods present technical challenges and have unreasonably time consuming post-processing. The aim of this study is to validate a full automated post-processing software for first pass perfusion CMR images that results in automated generated quantitative perfusion color maps.

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Department of Molecular Medicine and Surgery, Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospectively enroll 80 adult healthy volunteers (40 females and 40 males).

Description

Inclusion Criteria:

  • healthy individuals with normal 12-lead electrocardiogram at rest.

Exclusion Criteria:

  • systolic blood pressure below 90 mmHg;
  • bradycardia (< 45 heart beats/minute);
  • intake of caffeine or caffeine-containing drink/medicine 24 hours prior to the examination;
  • impaired renal function assessed by venous blood sample.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers
Healthy subjects with normal 12-lead electrocardiogram at rest.
Other: myocardial perfusion with magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of global myocardial first pass perfusion in mL/min/g measured in automatic post-processed color maps compared with myocardial blood volume measured in the coronary sinus (mL/min) divided by the total left ventricle mass (g)
Time Frame: Through study completion, an average of 9 months
Through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Martin Ugander, MD, PhD, Department of Molecular Medicine and Surgery, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUACK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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