UnknownEarly Phase 1

Catheter Directed Therapy in Intermediate Risk Pulmonary Embolism Patients

200 participantsStarted 2022-12-30

Plain-language summary

Aim of the work: 1. To compare conventional medical therapy versus catheter-directed therapy in intermediate high risk acute pulmonary embolism. 2. To define predictors of progression from intermediate to high-risk in medically-treated patients for ideal timing for intervention.

Who can participate

Age range

20 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Acute pulmonary embolism patients (confirmed by CT pulmonary angiography \[CTPA\]) * symptoms started within 15 days of enrollment * intermediate-high risk pulmonary embolism patients , i.e., who have all of the following risk indicators combined :(2) i.Pulmonary Embolism Severity Index (PESI) class III-V or sPESI ≥1, ii.AND RV dysfunction on TTE or CTPA, iii.AND elevated cardiac troponin levels * with none of the following high-risk presentations: cardiac arrest, systolic blood pressure \<90 mmHg, or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status, or end-organ hypoperfusion. Exclusion Criteria: * high risk patients who are hemodynamically unstable (cardiogenic shock, SBP \<90 mmHg, or use of intotropic support). * low risk patients with no RV dysfunction. * Patients with history of CTEPH (or previous acute PE) * Patients known to have other pulmonary hypertension, apart from group IV (CTEPH). * Patients with sever kidney injury (eGFR \<30 mg/dl/1.7m2).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients

Timeframe: up to 2 years

1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients

Timeframe: up to 2 years

1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients

Timeframe: up to 2 years

Trial details

NCT IDNCT05612854

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

Contact for this trial

Shrouk K Ali, MSc

+0201225134030 shrouk31@aun.edu.eg

View on ClinicalTrials.gov More Pulmonary Embolism Subacute Massive trials

Who can participate

Age range

20 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients

Timeframe: up to 2 years

1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients

Timeframe: up to 2 years

1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients

Timeframe: up to 2 years