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

Sponsor
Zulekha Hospitals (Other)
Overall Status
Completed
CT.gov ID
NCT05862220
Collaborator
(none)
28
1
25.5
1.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: D-Dimer vs CTPA

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 Design

Study Type:
Observational
Actual Enrollment :
28 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
A Single-center Study for the Correlation Between Computer Tomography Angiography and D-Dimer Level for the Diagnosis of Pulmonary Embolism
Actual Study Start Date :
Dec 14, 2020
Actual Primary Completion Date :
Jan 22, 2023
Actual Study Completion Date :
Jan 28, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. the robustness of d-dimer testing for PE compared to CTPA and identify the threshold values to support its use [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zulekha Hospitals Dubai United Arab Emirates 457

Sponsors and Collaborators

  • Zulekha Hospitals

Investigators

  • Study Chair: helena elizabith, consultant, Zulekha Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zulekha Hospitals
ClinicalTrials.gov Identifier:
NCT05862220
Other Study ID Numbers:
  • ZH-12-2022-01
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zulekha Hospitals
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2023