Correlation Between Computer Tomography Angiography and D-Dimer Level for the Diagnosis of Pulmonary Embolism

May 6, 2023 updated by: Zulekha Hospitals

A Single-center Study for the Correlation Between Computer Tomography Angiography and D-Dimer Level for the Diagnosis of Pulmonary Embolism

A blood sample was taken before starting the patients on any thrombolytic treatment. The positivity threshold for D-Dimer was above 250 ng/ml. CTPA was performed after performing blood sampling. Patients with confirmed pulmonary embolisms were admitted to ICU for continued monitoring of vitals, consciousness level, and signs of tissue perfusion. Signs of shock or hemodynamic instability should be observed regularly. Patients were managed in the ICU with anticoagulants by parenteral use. The most commonly used items were Heparin, either Unfractionated (UFH) or low-molecular-weight heparin (LMWH).D-dimer levels can leverage to detect PE. D-dimer levels can help in guiding the option of CTPA and the initiation of treatment for patients with suspected PE.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A blood sample was taken before starting the patients on any thrombolytic treatment. The positivity threshold for D-Dimer was above 250 ng/ml. CTPA was performed after performing blood sampling. Patients with confirmed pulmonary embolisms were admitted to ICU for continued monitoring of vitals, consciousness level, and signs of tissue perfusion. Signs of shock or hemodynamic instability should be observed regularly. Patients were managed in the ICU with anticoagulants by parenteral use. The most commonly used items were Heparin, either Unfractionated (UFH) or low-molecular-weight heparin (LMWH).Presenting symptoms were mainly dyspnea, chest pain or discomfort, cough, and shortness of breath. Twenty-four patients of the total number of cases were positive for CTPA while four patients were negative for PE by CTPA. embolism was detected in the anterior, posterior, medial, and lateral basal segmental branches of the right lung, the lateral, posterior, and anterior basal segmental branches of the left lung, and the posterior segmental branch of the left lung. The D-dimer test and CTPA both provided similarly accurate PE diagnoses with no significant differences between them. There were 28 patients total, 3 of those patients had D-dimer levels below the cut-off value of 250 ng/ml, whereas the remaining 25 had D-dimer levels over the diagnostic threshold. Those with a positive CTPA diagnosis of PE had greater levels of D dimers than those with a negative CTPA diagnosis of PE. plasma D-dimer concentration did not correlate with the cross-sectional diameter of the blocked pulmonary vessel.D-dimer levels can leverage to detect PE. D-dimer levels can help in guiding the option of CTPA and the initiation of treatment for patients with suspected PE.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

28 patients included, 14 patients female and 14 patients of male gender with an average age of 55.4 ±11.2 years. Presenting symptoms were mainly dyspnea, chest pain or, cough, and shortness of breath. Twenty-four patients of the total number of cases were positive for CTPA while four patients were negative for PE by CTPA. No allergy to the contrast was recorded during our study.

Description

Inclusion Criteria: Acute chest pain, dyspnea, tachypnea, and suspicion of PE -

Exclusion Criteria:the history of PE, the administration of anticoagulant medication before blood sampling, an allergic response to the CTPA contrast agent, impaired hepatic function or renal function, inability to cooperate during examinations, and an absence of relevant medical records for analyses

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
D-Dimer group
A blood sample was taken before starting the patients on any thrombolytic treatment. The latex agglutination test was used to measure plasma D-dimer level; this was done using a Sysmex CA-7000 automatic coagulation unit. The positivity threshold was above 250 ng/ml.
Diagnostic test: D-Dimer vs CTPA
CTPA was performed after performing blood sampling using Siemens Somatom definition AS 24 slice scanners. Non-ionic water-soluble contrast Omnipaque 350 mg I/mg or Visipaque 320 mg I/mg was injected at 4 mm/s maximum dose 100 ml using a Medtron pressure injector.OR, A blood sample was taken before starting the patients on any thrombolytic treatment. The latex agglutination test was used to measure plasma D-dimer level; this was done using a Sysmex CA-7000 automatic coagulation unit. The positivity threshold was above 250 ng/ml.
CTPA group
CTPA was performed after performing blood sampling using Siemens Somatom definition AS 24 slice scanners. Non-ionic water-soluble contrast Omnipaque 350 mg I/mg or Visipaque 320 mg I/mg was injected at 4 mm/s maximum dose 100 ml using a Medtron pressure injector.
Diagnostic test: D-Dimer vs CTPA
CTPA was performed after performing blood sampling using Siemens Somatom definition AS 24 slice scanners. Non-ionic water-soluble contrast Omnipaque 350 mg I/mg or Visipaque 320 mg I/mg was injected at 4 mm/s maximum dose 100 ml using a Medtron pressure injector.OR, A blood sample was taken before starting the patients on any thrombolytic treatment. The latex agglutination test was used to measure plasma D-dimer level; this was done using a Sysmex CA-7000 automatic coagulation unit. The positivity threshold was above 250 ng/ml.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the robustness of d-dimer testing for PE compared to CTPA and identify the threshold values to support its use
Time Frame: 26 MONTHS
the study aims to ascertain the robustness of d-dimer testing for PE compared to CTPA and identify the threshold values to support its use
26 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zulekha Hospitals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: helena elizabith, consultant, Zulekha Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZH-12-2022-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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