High-sensitivity C-reactive ProteinNCT07076745
High-Sensitive CRP and Carotid Stiffness Between Patients With and Without Coronary Slow Flow
An observational study of High-sensitivity C-reactive Protein and Carotid Stiffness, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to compare the levels of high-sensitivity C-reactive protein (hs-CRP) and carotid artery stiffness between patients with coronary slow flow phenomenon (CSFP) and those with normal coronary flow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-sensitivity C-reactive Protein, Carotid Stiffness, Coronary Slow Flow
- What is being tested?
- High-sensitivity C-reactive protein and Stiffness Measurement
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 10 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This case-control study will be conducted at Sohag University Hospitals after approval from the institutional ethical committee
Who may be able to join
- Age ≥18 years old.
- Both sexes.
- Patients undergo coronary angiography for evaluation of chest pain or suspected ischemia.
Who cannot join
- Pregnant or breastfeeding women.
- History of cardiovascular events such as myocardial infarction or stroke.
- Diagnosed autoimmune disorders, chronic hepatic or renal diseases.
- Current or recent infections.
- History of malignancy.
- Patients taking medications known to affect inflammatory markers (e.g., corticosteroids or immunosuppressants).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Assessment of High Sensitive CRP and Carotid Stiffness Between Patients With and Without Coronary Slow Flow
This study aims to compare the levels of high-sensitivity C-reactive protein (hs-CRP) and carotid artery stiffness between patients with coronary slow flow phenomenon (CSFP) and those with normal coronary flow.
Read the detailed description
The coronary slow flow phenomenon (CSFP) is characterized by delayed opacification of the coronary arteries during angiography in the absence of significant epicardial coronary artery disease.
Hypothesis: High-sensitivity C-reactive protein (hs-CRP) is a well-established biomarker of systemic inflammation and has been associated with various cardiovascular conditions. Elevated hs-CRP levels have been observed in patients with CSFP, suggesting an inflammatory component in its pathogenesis. This marker not only predicts future cardiovascular events but may also reflect ongoing vascular inflammation in patients with angiographically normal coronary arteries.
- Being tested
- High-sensitivity C-reactive protein, Stiffness Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-sensitivity C-reactive proteinDiagnostic test
High-sensitivity C-reactive protein will be done.
Stiffness MeasurementOther
Measurements will include carotid intima-media thickness (CIMT), systolic (Ds) and diastolic (Dd) diameters, and calculation of stiffness indices:
- β-stiffness index.
- Peterson's elastic modulus (Ep).
- Distensibility coefficient (DC).
- Compliance coefficient (CC).
- Strain.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients diagnosed with coronary slow flow based on corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC) >27. Receives: Diagnostic Test: High-sensitivity C-reactive protein; Other: Stiffness Measurement | |
| Control group | Patients with normal coronary angiographic flow and no obstructive coronary artery disease. Receives: Diagnostic Test: High-sensitivity C-reactive protein; Other: Stiffness Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Sensitive C-reactive protein
High Sensitive C-reactive protein will be measured.
Measured: 24 hours post-angiography
Secondary outcomes (1)
Stiffness indices
Stiffness indices will be measured.
Measured: 24 hours post-angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2025
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-sensitivity C-reactive ProteinStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remon Saleh Adly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076745
- Sponsor's protocol ID
- Soh-Med-25-5-6PD
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of High Sensitive CRP and Carotid Stiffness Between Patients With and Without Coronary Slow Flow
- ClinicalTrials.gov ID
- NCT07076745
- Acronym / sponsor ID
- Soh-Med-25-5-6PD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 22 Jul 2025 (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.
This study aims to compare the levels of high-sensitivity C-reactive protein (hs-CRP) and carotid artery stiffness between patients with coronary slow flow phenomenon (CSFP) and those with normal coronary flow.
Detailed description
The coronary slow flow phenomenon (CSFP) is characterized by delayed opacification of the coronary arteries during angiography in the absence of significant epicardial coronary artery disease.
Hypothesis: High-sensitivity C-reactive protein (hs-CRP) is a well-established biomarker of systemic inflammation and has been associated with various cardiovascular conditions. Elevated hs-CRP levels have been observed in patients with CSFP, suggesting an inflammatory component in its pathogenesis. This marker not only predicts future cardiovascular events but may also reflect ongoing vascular inflammation in patients with angiographically normal coronary arteries.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: High-sensitivity C-reactive protein, Other: Stiffness MeasurementPatients diagnosed with coronary slow flow based on corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC) >27. |
| Control group | – | Diagnostic Test: High-sensitivity C-reactive protein, Other: Stiffness MeasurementPatients with normal coronary angiographic flow and no obstructive coronary artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This case-control study will be conducted at Sohag University Hospitals after approval from the institutional ethical committee
Key inclusion criteria (3 listed)
- Age ≥18 years old.
- Both sexes.
- Patients undergo coronary angiography for evaluation of chest pain or suspected ischemia.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women.
- History of cardiovascular events such as myocardial infarction or stroke.
- Diagnosed autoimmune disorders, chronic hepatic or renal diseases.
- Current or recent infections.
- History of malignancy.
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 |
|---|---|---|
| High-sensitivity C-reactive proteinHigh-sensitivity C-reactive protein will be done. | Diagnostic test | Control group, Study group |
| Stiffness MeasurementMeasurements will include carotid intima-media thickness (CIMT), systolic (Ds) and diastolic (Dd) diameters, and calculation of stiffness indices: * β-stiffness index. * Peterson's elastic modulus (Ep). * Distensibility coefficient (DC). * Compliance coefficient (CC). * Strain. | Other | Control group, Study group |
Primary outcome
High Sensitive C-reactive protein
Time frame: 24 hours post-angiography
High Sensitive C-reactive protein will be measured.
1 secondary outcome
Stiffness indices
Time frame: 24 hours post-angiography
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 22 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 High-sensitivity C-reactive Protein and Carotid Stiffness, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. 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 22 Jul 2025. 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 Egypt. 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?
High Sensitive C-reactive protein (time frame: 24 hours post-angiography). 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 22 Jul 2025.