Contrast Enhanced PA Pressure Measurements

NCT06240871 | Completed

• 1 other identifier: STU00071358
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary hypertension (PH) is an abnormal increase of the pressure inside the lung circulation. This condition can be caused by many different diseases. If PH persists for a long period of time, irreversible damage to the lung circulation and to the heart may ensue. A definitive diagnosis of PH requires direct measurement of the pressure within the lung circulation with a procedure called right heart catheterization (RHC). While overall safe, RHC is an invasive procedure and is associated with a small risk of complications (\~1.1%) and, very rarely, death (0.055%), even when performed in experienced laboratories. Therefore, alternative diagnostic approaches are often employed such as an ultrasound technique called Doppler echocardiography which is non-invasive, relatively inexpensive and widely available technique. It is suitable not only as a screening tool but also for serial monitoring of disease progression in PH. However, the accuracy of Doppler echocardiography in measuring pressure in the lung circulation appears to be modest in patients with suspected PH. To improve the performance of Doppler echocardiography it is common practice to inject a small amount of agitated saline or an echocardiographic contrast medium (usually composed of microbubbles of fat containing a minuscule amount of a gas) into a vein. However, the accuracy of using agitated saline or a contrast agent in the measurement of pressures inside the lung circulation has not been established. The proposed study will assess the accuracy of Doppler echocardiographic measurements of pressures in the pulmonary circulation by simultaneously comparing the pressures collected during a RHC. The investigators will enroll 100 consecutive patients undergoing RHC in the Catheterization Laboratory of Northwestern Memorial Hospital. The investigators will measure pulmonary pressures by RHC and by Doppler echocardiography at baseline and following the injection of agitated saline as well as Optison®, an FDA-approved contrast agent commonly used in the echo laboratory. The investigators will then determine the accuracy of the Doppler echocardiography measurement without and with the use of agitated saline or Optison® with the measurements obtained during the RHC which is the gold standard. The results of this study will allow determination whether the use of echo contrast improves the accuracy of Doppler echocardiography and whether contrast-enhanced Doppler measurements are a clinically useful alternative to RHC measurements.

Conditions

Pulmonary Hypertension

Keywords

Echo; PA pressures; comparison; Right Heart Catheterization

Outcome Measures

Primary Outcomes (1)

• Simultaneous Noninvasive and Invasive measurements of PA pressures

  Doppler echo measurements: Estimated pulmonary artery (PA) systolic pressure without any contrast (units = mmHg) Estimated PA systolic pressure with agitated saline contrast (units = mmHg) Estimated PA systolic pressure with echocardiographic contrast (units = mmHg) Right heart catheterization (RHC) measurements: Invasively measured PA systolic pressure (units = mmHg)

  Data acquisition wll be obtained as soon as the RHC is performed, expected average of 5 weeks

Secondary Outcomes (1)

• Simultaneous assessment of IVC collapsibility and invasive right atrial pressure measurement

  Immediately will be noted as soon as PHC is performed, expected average of 5weeks

Study Arms (1)

Pulmonary artery pressure measurements

The investigators will compare noninvasive right sided pressure measurements with invasive right heart catheterization performed in 3 steps:at rest, with agitated saline and with agitated echo contrast, Optison. This was not a clinical trial and there were no intervention arms per se. All patients received agitated saline and echocardiographic contrast.

Other: Pulmonary artery pressure measurements

Interventions

Pulmonary artery pressure measurements OTHER

The investigators will compare noninvasive measurements of right sided pressure measurements with invasive RHC performed in 3 steps:at rest, with agitated saline and with agitated echo contrast, Optison. This was not a clinical trial and there were no intervention arms per se. All patients received agitated saline and echocardiographic contrast.

Pulmonary artery pressure measurements

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Unselected consecutively patients 18 to 80 years old referred for RHC to the Cardiac Catheterization Laboratory of Northwestern Memorial Hospital.

You may qualify if:

• Unselected consecutively patients 18 to 80 years old referred for RHC to the Cardiac Catheterization Laboratory of Northwestern Memorial Hospital. The informed consent for RHC will be obtained as part of the clinical assessment.

You may not qualify if:

• Severe pulmonary hypertension that is O2-dependent
• History of allergy to Optison®
• Hypersensitivity to perflutren, blood, blood products or albumin
• History of patent foramen ovale (PFO) or atrial septal defect (ASD)
• Known or suspected right-to-left, bi-directional, or transient right-to- left cardiac shunts
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• Northwestern University: lead
• GE Healthcare: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Galie N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G; ESC Committee for Practice Guidelines (CPG). Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J. 2009 Oct;30(20):2493-537. doi: 10.1093/eurheartj/ehp297. Epub 2009 Aug 27. No abstract available.

  PMID: 19713419 RESULT

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kameswari Maganti

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: February 5, 2024
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

US (1)