NCT05568927: ValidSEARCH

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

Completed Last updated 4 November 2025

What this trial tests

trial testing SEARCH algorithm in Pulmonary Embolism in 150 participants. Completed in 13 June 2025.

Timeline

15 November 2022

Primary endpoint
13 June 2025

13 June 2025

Quick facts

Lead sponsor	University of California, San Diego
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	15 November 2022
Primary completion	13 June 2025
Estimated completion	13 June 2025
Sites	8 locations across United States

Drugs / interventions tested

• SEARCH algorithm

Conditions studied

• Pulmonary Embolism — all drugs for Pulmonary Embolism →
• Chronic Thromboembolic Pulmonary Hypertension — all drugs for Chronic Thromboembolic Pulmonary Hypertension →

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with Pulmonary Embolism or Chronic Thromboembolic Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Observational cohort study to validate SEARCH, a novel hierarchical algorithm to define long-term outcomes after pulmonary embolism.
   Morris TA, Fernandes TM, Chung J, Vintch JRE, et al · · 2023 · cited 2× · PMID 37770267 · DOI 10.1136/bmjopen-2023-074470