129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

∙ (Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial)

• Outpatients of either gender, age \> 18

• Willing and able to give informed consent and adhere to visit/protocol (Consent must be given before any study procedures are performed.)

• Subject has no diagnosed pulmonary conditions

• Subject has not smoked in the previous 5 years

• Smoking history, if any, is less than or equal to 5 pack-years

• No history of using other inhaled products more than 1/week for \> 1 year

• In-patient or outpatients of either sex, age \> 18

• Willing and able to give informed consent and adhere to visit/protocol

∙ And one of the following:

• Patients who are scheduled to receive a red cell transfusion for anemia.

• Patients who are scheduled to undergo therapeutic phlebotomy to treat erythrocytosis or polycythemia

• Healthy volunteers undergoing voluntary whole blood donation (healthy volunteer inclusion criteria noted above)

• In-patient or outpatients of either sex, age \> 18

• Willing and able to give informed consent and adhere to visit/protocol

∙ And one of the following categories (ILD, Dyspnea, CTEPH, or Healthy):

• Interstitial Lung Disease or Dyspnea

‣ Physician diagnosis of Interstitial Lung Disease by a pulmonologist using established criteria or physician referral of patient with dyspnea

• OR

• Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

‣ Patients with a diagnosis of CTEPH, defined as mean PA pressure \>20 mmHg with a pulmonary vascular resistance \>2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation

⁃ Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans

• OR

• Healthy Volunteer (criteria noted above)

• In-patient or outpatients of either sex, age \> 18

• Willing and able to give informed consent and adhere to visit/protocol

∙ And one of the following categories (Acute or Chronic)

• Acute Pulmonary Embolism

‣ Patients presenting with acute PE 24-48hrs post-admission

⁃ Willing to return after 3-6 months of anti-coagulation therapy

• OR

• Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

‣ Patients with a diagnosis of CTEPH, defined as mean PA pressure \>20 mmHg with a pulmonary vascular resistance \>2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation

⁃ Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
Bastiaan Driehuys, PhD
bastiaan.driehuys@duke.edu
919-684-7786
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 125
Treatments
Active_comparator: Transfusion and Phlebotomy Patients
Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood.
Active_comparator: Oxygen Administration Patients
Individuals diagnosed with a chronic blood clot in their lungs and are planning on having surgery to remove it (CTEPH), or have an interstitial lung disease (ILD), or have dyspnea, or are a healthy volunteer.
Active_comparator: Acute or Chronic Pulmonary Embolism Patients
Individuals recently diagnosed with a blood clot in their lungs.
Sponsors
Leads: Bastiaan Driehuys
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov