NCT06038630Toboroz2. fázis
129Xe MRI Cardiopulmonary
129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 4.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 125 (tervezett)
- Első benyújtás
- 2023. szept. 8.
- Kezdés
- 2024. jan. 12.
- Elsődleges befejezés
- 2028. jún. 30.
- Fő szponzor
- Bastiaan Driehuys
- Betegségek
- Pulmonális artériás hipertónia
- NCT-szám
- NCT06038630
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 125
- 2024. jan. 12. és az elsődleges befejezés (2028. jún. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject has history of any known ventricular cardiac arrhythmia
- Subject has history of cardiac arrest within the last year
- Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Egyéb
- Subjects presenting with any of the following will not be included in the trial:
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Resting O2 saturation <90% with maximum supplemental O2 delivered by nasal canula
- Subject does not fit into 129Xe vest coil used for MRI
- Subject cannot hold his/her breath for 10 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
Kiket keres a vizsgálat
- (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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Duke University Medical Center | Durham | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.