Ventilation and Perfusion Scan in Pulmonary Embolism Following Catheter Directed Thrombectomy Versus Anticoagulation Alone (VQPE)

Ventilation and Perfusion Imaging in Acute Pulmonary Embolism Following Catheter Directed Aspiration Thrombectomy Versus Conservative Therapy Alone: A Pilot Study

Clinical presentation of acute pulmonary embolism (PE) is complex and varied and not uncommonly involves respiratory failure with dyspnea or hypoxia. Patients with persisting signs of respiratory failure despite anticoagulation, may benefit from catheter directed thrombectomy. Additionally, patient who receive thrombectomy are likely to have a lower residual thrombus burden measurable by ventilation-perfusion (V/Q) scan, and thereby less likely to develop chronic sequela, including chronic thromboembolic pulmonary hypertension (CTEPH) and post PE syndrome.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension; Pulmonary Embolism; Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: Device: Catheter directed therapy; Drug: Systemic anticoagulation

Detailed Description

Acute pulmonary embolism (PE) is a common disease with variable presentation and clinical outcomes. Chronic sequelae including chronic thromboembolic pulmonary hypertension (CTEPH) and post-PE syndrome are common pathologies for patient who survive the already significant inpatient mortality, and have a significant impact on both quality of life and life expectancy. To date, the ELOPE trial is the only study to prospectively compare quality of life (QoL) and dyspnea measures and six-minute walk distance (6MWD) to cardiopulmonary exercise test, revealing worse post-PE syndrome in select populations, however this study is limited to a single arm that received anticoagulation alone. New catheter directed therapies, developed in response to such poor outcomes, provide treatment options for acute PE patients when first line therapies including anticoagulation are contraindicated or have failed.

Long term studies utilizing imaging have shown a majority of patients diagnosed with PE have residual pulmonary thrombi after 6 months, which is likely to be a large contributor to the development of CTEPH. Ventilation-perfusion (V/Q) scans remain the gold standard for detection of both acute and chronic pulmonary embolism and will serve as a primary outcome measure at 6 months post initial treatment. Clinical measures including 6MWD, QoL and dyspnea questionaries will be assessed prior to discharge, and at 1 and 6 months, in order to characterize the development of chronic symptomatology.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Carol Stuehm; Phone Number: 520-626-8318; Email: carols@email.arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • Recruiting
      • Banner University Medical Center
      • Sub-Investigator: Michael Kendall, MD
      • Sub-Investigator: Abdul Khan, MD
      • Sub-Investigator: Tammer El-Aini, MD
      • Sub-Investigator: Michael Insel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring treatment for acute pulmonary embolism.

Description

Inclusion Criteria:

1. Age >18 years
2. Clinical signs and symptoms consistent with acute PE
3. Echocardiogram, CT pulmonary angiogram (CTPA) or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
4. Scheduled for PE treatment with catheter directed therapy and systemic anticoagulation or anticoagulation alone per the investigator's discretion
5. Signs of respiratory failure including a. arterial blood saturation <90%, or b. partial arterial oxygen pressure <60 mmHg, or c. persistent tachypnea with respiratory rates > 20/min

Exclusion Criteria:

1. Unable to be anticoagulated with heparin or alternative therapy
2. Diagnosis with a minor PE without signs of right ventricular (RV) dysfunction
3. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
4. Imaging evidence or other evidence that suggests, in opinion of the Investigator, the patient is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location or predominately chronic clot)
5. Life expectancy <6 months, as determined by the Investigator

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Catheter directed thrombectomy	Device: Catheter directed therapy; Thrombectomy; Drug: Systemic anticoagulation; Conservative therapy
Systemic anticoagulation	Drug: Systemic anticoagulation; Conservative therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation-perfusion mismatch	Mismatch on ventilation-perfusion scintigraphy per Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) criteria	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life questionnaire	6 months
6-minute walk distance	30 days
6-minute walk distance	6 months
Hospital length of stay	Up to 30 days
Dyspnea questionnaire	up to 72 hours
Dyspnea questionnaire	30 days
Dyspnea questionnaire	6 months
Quality of life questionnaire	30 days

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: Inari Medical

Publications and helpful links

General Publications

• Kahn SR, Hirsch AM, Akaberi A, Hernandez P, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Geerts WH, Aaron SD, Granton JT. Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. Chest. 2017 May;151(5):1058-1068. doi: 10.1016/j.chest.2016.11.030. Epub 2016 Dec 6.
• Kahn SR, Akaberi A, Granton JT, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Hernandez P, Aaron SD, Hirsch AM. Quality of Life, Dyspnea, and Functional Exercise Capacity Following a First Episode of Pulmonary Embolism: Results of the ELOPE Cohort Study. Am J Med. 2017 Aug;130(8):990.e9-990.e21. doi: 10.1016/j.amjmed.2017.03.033. Epub 2017 Apr 8.
• Nijkeuter M, Hovens MM, Davidson BL, Huisman MV. Resolution of thromboemboli in patients with acute pulmonary embolism: a systematic review. Chest. 2006 Jan;129(1):192-7. doi: 10.1378/chest.129.1.192.
• Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5.
• Piazza G, Goldhaber SZ. Chronic thromboembolic pulmonary hypertension. N Engl J Med. 2011 Jan 27;364(4):351-60. doi: 10.1056/NEJMra0910203. No abstract available.
• Casazza F, Becattini C, Bongarzoni A, Cuccia C, Roncon L, Favretto G, Zonzin P, Pignataro L, Agnelli G. Clinical features and short term outcomes of patients with acute pulmonary embolism. The Italian Pulmonary Embolism Registry (IPER). Thromb Res. 2012 Dec;130(6):847-52. doi: 10.1016/j.thromres.2012.08.292. Epub 2012 Aug 24.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Hypertension; Embolism; Hypertension, Pulmonary; Pulmonary Embolism
• Other Study ID Numbers: STUDY00000091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No