Validation of SEARCH, a Novel Hierarchical Algorithm to Define Long-term Outcomes After Pulmonary Embolism

NCT05568927 | Completed

• 1 other identifier: Inari-RG-2022-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 8

Brief Summary

Potential outcomes after PE occur on a spectrum: complete recovery, exercise intolerance from deconditioning/anxiety, dyspnea from concomitant cardiopulmonary conditions, dyspnea from residual pulmonary vascular occlusion, chronic thromboembolic disease and chronic thromboembolic pulmonary hypertension. Although a battery of advanced diagnostic tests could distinguish each of those conditions, the yield of individual tests among all post- PE patients is low enough that routine testing of all PE patients is not typically performed. Although the various possible post-PE outcomes have enormous implications for patient care, they are rarely distinguished clinically. Perhaps for this reason, chronic conditions after PE are rarely (if ever) used as endpoints in randomized clinical trials of acute PE treatment. The proposed project will validate a clinical decision tree to distinguish among the various discrete outcomes cost-effectively through a hierarchical series of tests with the acronym SEARCH (for symptom screen, exercise function, arterial perfusion, resting heart function, confirmatory imaging and hemodynamics). Each step of the algorithm sorts a subset of patients into a diagnostic category unequivocally in a cost-effective manner. The categories are mutually exclusive and collectively exhaustive, so that each case falls into one, and only one, category. Each individual test used in the algorithm has been clinically validated in pulmonary embolism patients, including the cardiopulmonary exercise test (CPET) technique that the investigators developed and validated. However, the decision tree approach to deploying the tests has not yet been validated. Aim 1 will determine whether the SEARCH algorithm will yield concordant post-PE diagnoses when multiple reviewers independently evaluate multiple cases (reliability). Aim 2 will determine whether the post-PE diagnoses are stable, according to the SEARCH algorithm, between the first evaluation and the subsequent one six months later (validity).

Conditions

Pulmonary Embolism; Chronic Thromboembolic Pulmonary Hypertension

Keywords

Clinical validation

Outcome Measures

Primary Outcomes (2)

• Interobserver agreement among readers regarding the clinical condition during the first evaluation point: at least three months after acute PE.

  Based on a structured evaluation of clinical data generated during long term follow-up after PE and presented in a de-identified manner, six observers will independently categorize each patient as one of the following: 1. complete recovery from dyspnea and exercise intolerance to the state that pre-existed PE or dyspnea after PE but cardiopulmonary exercise test showing normal ventilatory dead space proportions (VD/VT) and normal estimated stroke volume augmentation (SVA) during exercise; 2. dyspnea after PE likely due to alternative diagnoses; 3. dyspnea after PE with increased VD/VT or decreased SVA during exercise in the presence of residual pulmonary vascular occlusion (RPVO) but without hemodynamic measurement; 4. symptomatic RPVO or chronic thromboembolic disease (CTED) documented by hemodynamic measurement; 5. chronic thromboembolic pulmonary hypertension (CTEPH) documented by hemodynamic measurement.

  Each presentation will summarize clinical data leading up to and including an assessment time point at least 3 months after the onset of acute PE

• Interobserver agreement among readers regarding clinical condition at the second evaluation point.

  Based on a structured evaluation of clinical data generated during long term follow-up after PE and presented in a de-identified manner, six observers will independently categorize each patient as one of the following: 1. complete recovery from dyspnea and exercise intolerance to the state that pre-existed PE or dyspnea after PE but cardiopulmonary exercise test showing normal VD/VT and normal estimated SVA during exercise; 2. dyspnea after PE likely due to alternative diagnoses; 3. dyspnea after PE with increased VD/VT or decreased SVA during exercise in the presence of RPVO but without hemodynamic measurement; 4. symptomatic RPVO or CTED documented by hemodynamic measurement; 5. CTEPH documented by hemodynamic measurement; 6. death prior to the evaluation point.

  Each presentation will summarize clinical data leading up to and including an assessment time point at least 6 months after the first assessment (described under Aim 1a)

Secondary Outcomes (1)

• Constancy of diagnosis between first evaluation point and second evaluation point

  Stability between the two time points will be determined after the presentation and evaluation of the 12-month time point

Study Arms (1)

Post-pulmonary embolism patients

Consecutive patients who, during the study period, underwent the SEARCH algorithm to a diagnostic endpoint at one of the UCAPE network of outpatient pulmonary embolism clinics (UC San Diego, UC Irvine, UC Los Angeles-Harbor, UC Los Angeles, UC Riverside, UC Davis, UC San Francisco or UC San Francisco-Fresno) three months or more after the occurrence of acute pulmonary embolism or any risk type. The SEARCH algorithm is the standard of care throughout the UCAPE network, so the experimental portion of this study is limited to the reporting of the (de-identified) results to the evaluation group and the analyses described in Aims 1 and 2. However, there may be patients who are lost to follow up or have other reasons for which the SEARCH algorithm is not followed. Those patients will not be included in the study. The numbers of such patients will be recorded at each center.

Other: SEARCH algorithm

Interventions

SEARCH algorithm OTHER

The SEARCH algorithm is a structured, stepwise approach to follow up testing after acute PE that will enable timely diagnosis of post PE sequelae. The test results at each step inform the performance of the subsequent steps. The order of the tests in the algorithm uses the acronym SEARCH: Symptom screen, exercise function, arterial perfusion, resting heart function, confirmatory imaging, and hemodynamics.

Post-pulmonary embolism patients

Eligibility Criteria

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

Study Population

The study will recruit consecutive patients who, during the study period, underwent the SEARCH algorithm at one of the UCAPE network of outpatient pulmonary embolism clinics (UC San Diego, UC Irvine, UCLA Harbor, UCLA, UC Riverside, UC Davis, UC San Francisco or UCSF Fresno) three months or more after the occurrence of acute pulmonary embolism or any risk type.

You may qualify if:

• age 18 years or greater
• objective evidence of acute pulmonary thrombo-embolism at least six months before the evaluation
• anticipated survival for at least three months
• a diagnostic endpoint in the SEARCH algorithm has been reached.

You may not qualify if:

• ● Cases in which the clinical presentations contain insufficient interpretable data to permit evaluation of SEARCH criteria, as described in the Study Design section, will be excluded from the analysis.

Sponsors & Collaborators

• University of California, San Diego: lead
• Inari Medical: collaborator

Study Sites (8)

University of California, San Francisco-Fresno

Fresno, California, 93701, United States

Location

University of California, Irvine

Irvine, California, 92868, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University Hospital, Riverside

Moreno Valley, California, 92555, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of California, Los Angeles - Harbor

Torrance, California, 90502, United States

Location

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  PMID: 37770267 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Timothy A Morris, MD

  University of California, San Diego Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 6, 2022
• Study Start: November 15, 2022
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)