NCT01451255

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

October 8, 2011

Last Update Submit

March 15, 2016

Conditions

Keywords

pulsatilitynormal subjectsmild pulmonary hypertensionexercise-associated pulmonary hypertension

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

  • Ray JC, Burger C, Mergo P, Safford R, Blackshear J, Austin C, Fairweather D, Heckman MG, Zeiger T, Dubin M, Shapiro B. Pulmonary arterial stiffness assessed by cardiovascular magnetic resonance imaging is a predictor of mild pulmonary arterial hypertension. Int J Cardiovasc Imaging. 2019 Oct;35(10):1881-1892. doi: 10.1007/s10554-018-1397-y. Epub 2018 Jun 22.

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Brian Shapiro, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2011

First Posted

October 13, 2011

Study Start

August 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations