Fibrinolytic Deficit in Patients With Acute PE
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ClinicalTrials.gov Identifier: NCT04480892 |
Recruitment Status :
Not yet recruiting
First Posted : July 22, 2020
Last Update Posted : July 22, 2020
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Condition or disease |
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Acute Pulmonary Embolism Fibrinolytic Deficit |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Day |
Official Title: | Fibrinolytic Deficit in Patients With Acute Pulmonary Embolism |
Estimated Study Start Date : | August 2020 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2024 |
- Plasminogen Activator Inhibitor-1 (PAI-1) [ Time Frame: Baseline-Day 1 ]Laboratory analysis of blood sample for PAI-1 level
- Alpha-2 Antiplasmin level (A2P) [ Time Frame: Baseline-Day 1 ]Laboratory analysis of blood sample for A2P level
- Thrombin Activatable Fibrinolysis Inhibitor (TAFI) [ Time Frame: Baseline-Day 1 ]Laboratory analysis of blood sample for TAFI level
- Tissue plasminogen activator (tPA) [ Time Frame: Baseline-Day 1 ]Laboratory analysis of blood sample for tPA level
- D-dimer [ Time Frame: Baseline-Day 1 ]Laboratory analysis of blood sample for D-dimer level
- Plasminogen [ Time Frame: Baseline-Day 1 ]Laboratory analysis of blood sample for Plasminogen level
- Fibrinogen [ Time Frame: Baseline-Day 1 ]Laboratory analysis of blood sample for Fibrinogen level
- Clinical Presentation Risk Score [ Time Frame: Baseline-Day 1 ]Based on vital signs (heart rate, blood pressure, oxygen requirements, and labs (CBC, lactate, troponin, and BNP, clinical presentation will be characterized as low, intermediate, or high risk.
- Right Ventricular Function [ Time Frame: Baseline-Day 1 ]Assessed by echocardiography
- Pulmonary Artery Pressure [ Time Frame: Baseline-Day 1 ]Pulmonary Artery Pressure (mmHg) will be measured for patients escalated to endovascular therapies in the cardiac cath laboratory
- Cardiac Output [ Time Frame: Baseline-Day 1 ]Cardiac Output, the volume of blood pumped from the ventricle per heartbeat (mL/min), will be measured for patients escalated to endovascular therapies in the cardiac cath laboratory.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients age 18 - 90 years
- Patients suffering an acute PE
- Blood collected for clinical evaluation of PE
Exclusion Criteria:
- Blood not collected or not sufficient quantity/quality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480892
Contact: Amir Darki, MD | 708-216-4466 | adarki@lumc.edu |
United States, Illinois | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Contact: Amir Darki, MD 708-216-4466 adarki@lumc.edu | |
Sub-Investigator: Debra Hoppensteadt-Moorman, PhD |
Principal Investigator: | Amir Darki, MD | Loyola University |
Responsible Party: | Amir Darki, Associate Professor, Loyola University |
ClinicalTrials.gov Identifier: | NCT04480892 |
Other Study ID Numbers: |
212490 |
First Posted: | July 22, 2020 Key Record Dates |
Last Update Posted: | July 22, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Acute Pulmonary Embolism Fibrinolytic System Fibrinolysis |
Pulmonary Embolism Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |