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Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01451255
First Posted: October 13, 2011
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian Shapiro, Mayo Clinic
  Purpose
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).

Condition
Pulmonary Hypertension Pulmonary Arterial Hypertension

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Brian Shapiro, Mayo Clinic:

Enrollment: 90
Study Start Date: August 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451255


Locations
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Brian Shapiro, M.D. Mayo Clinic Florida
  More Information

Responsible Party: Brian Shapiro, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01451255     History of Changes
Other Study ID Numbers: 11-002576
First Submitted: October 8, 2011
First Posted: October 13, 2011
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by Brian Shapiro, Mayo Clinic:
pulsatility
normal subjects
mild pulmonary hypertension
exercise-associated pulmonary hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases