D-Dimer as an Early Detector of Pulmonary EmbolismNCT05862220
Correlation Between Computer Tomography Angiography and D-Dimer Level for the Diagnosis of Pulmonary Embolism
An observational study of D-Dimer as an Early Detector of Pulmonary Embolism, run by Zulekha Hospitals at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- D-Dimer as an Early Detector of Pulmonary Embolism
- What is being tested?
- D-Dimer vs CTPA
- How many people
- 28 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 14 Dec 2020to 28 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- D-Dimer vs CTPA
- Keywords
- D-Dimer, Pulmonary, Embolism, CTPA.
- Medical subject headings
- Embolism, Cataract, posterior polar, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-Dimer vs CTPADiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: D-Dimer vs CTPA | |
| 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. Receives: Diagnostic Test: D-Dimer vs CTPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
the robustness of d-dimer testing for PE compared to CTPA and identify the threshold values to support its use
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
Measured: 26 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start14 Dec 2020
- Primary completion22 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D-Dimer as an Early Detector of Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zulekha Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- helena elizabith, consultant, Study chair, Zulekha Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862220
- Sponsor's protocol ID
- ZH-12-2022-01
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Study for the Correlation Between Computer Tomography Angiography and D-Dimer Level for the Diagnosis of Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05862220
- Acronym / sponsor ID
- ZH-12-2022-01
- Keywords
- D-Dimer, Pulmonary, Embolism, CTPA.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Zulekha HospitalsUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 22 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-Dimer group | – | Diagnostic Test: D-Dimer vs CTPAA 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 | – | Diagnostic Test: D-Dimer vs CTPACTPA 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. |
Who may qualify
- Ages
- 22 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-Dimer vs CTPACTPA 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. | Diagnostic test | CTPA group, D-Dimer group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
helena elizabith, consultant study chair
Zulekha Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of D-Dimer as an Early Detector of Pulmonary Embolism, run by Zulekha Hospitals at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the robustness of d-dimer testing for PE compared to CTPA and identify the threshold values to support its use (time frame: 26 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.