Pulmonary HypertensionNCT01451255
Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging
An observational study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Mayo Clinic at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Arterial Hypertension
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Consecutive patients aged ≥ 18 years with PAH as dictated by a comprehensive examination and echocardiography will be included for enrollment.
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic
Jacksonville, Florida, 32224
About this study
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).
- Keywords
- pulsatility, normal subjects, mild pulmonary hypertension, exercise-associated pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Shapiro, Mayo Clinic
- Investigators
- Brian Shapiro, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451255
- Sponsor's protocol ID
- 11-002576
- Status last verified
- Mar 2016
- First submitted
- 8 Oct 2011
- Last updated
- 17 Mar 2016
- Results posted
- No
Publications
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.
PubMed 29934885
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01451255
- Acronym / sponsor ID
- 11-002576
- Keywords
- pulsatility, normal subjects, mild pulmonary hypertension, exercise-associated pulmonary hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Consecutive patients aged ≥ 18 years with PAH as dictated by a comprehensive examination and echocardiography will be included for enrollment.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Derived from this study: PubMed 29934885Ray 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Shapiro, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01451255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.