Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging

March 15, 2016 updated by: Brian Shapiro, Mayo Clinic
Cardiac magnetic resonance imaging has emerged as a potential valuable test for the early detection of Pulmonary Arterial Hypertension. A number of reports have provided some preliminary evidence that Pulmonary Artery (PA) stiffness may be accurately detected by imaging of the pulmonary artery in order to measure PA stiffness. In addition, cardiac MRI could play provide early and effective treatment for Pulmonary Arterial Hypertension (PAH).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

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

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

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 to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population will consist of a total of 90 subjects separated evenly into the following subgroups: 1) Mild PAH, 2) Moderate or Severe PAH, and 3) Normal Controls.

Description

Inclusion Criteria:

Consecutive patients aged ≥ 18 years with PAH as dictated by a comprehensive examination and echocardiography will be included for enrollment.

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Mechanical ventilation
  • Acute or chronic renal failure (creatinine clearance < 30 ml/min or requiring renal replacement therapy)
  • Inability to perform MRI (i.e. claustrophobia, severe obesity (> 150 kg), device incompatible with MRI)
  • Significant arrhythmia that precludes adequate ECG-gating for the MRI (i.e. atrial fibrillation with highly variable cycle lengths)
  • Prior heart or lung transplantation
  • Left ventricular systolic (ejection fraction < 50%) or diastolic failure (based on Framingham criteria for heart failure with preserved ejection fraction)
  • Significant left-sided valvular disease (≥ moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation) or prior valve surgery

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

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Brian Shapiro, M.D., Mayo Clinic

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

August 1, 2011

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

October 8, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (ESTIMATE)

October 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-002576

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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