Contrast-induced NephropathyPhase 4NCT06429345
Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients.
A Phase 4 study testing Coenzyme Q10 100 Milligrams Oral Capsule in people with Contrast-induced Nephropathy, run by Ain Shams University at 2 sites in Egypt.
Trial summary
In this study the investigators aim to study the effect of supplementation of CoQ10 in decreasing the incidence of contrast induced acute kidney injury in patients with acute coronary syndrome undergoing coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-induced Nephropathy
- What is being tested?
- Coenzyme Q10 100 Milligrams Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jun 2024to 1 Nov 2024
- Phase
- Phase 4
- 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
Who may be able to join
- Patients who are 18 years or older.
- ST-elevation myocardial infarction (STEMI).
- Non ST-elevation myocardial infarction( NSTEMI).
- Unstable Angina (UA)
Who cannot join
- Renal transplant patients.
- Preoperative bleeding .
- Intraoperative bleeding or hypotension.
- Patients taking any nephrotoxic medications
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ain Shams university hospitals
Cairo
Ain shams University
- Not yet recruiting
Ramy Mohamed Mostafa
Cairo
Ramy Mostafa, Resident, 01002820102, 96ramymohamed22@gmail.com
Ramy Mohamed Mostafa, Resident, 01002820102, 96ramymohamed22@gmail.com
About this study
Official title: Possible Role of Coenzyme Q10 in Prevention of Contrast Induced Nephropathy in Patients With Acute Coronary Syndrome Undergoing Coronary Angiography With or Without Intervention.
In this study the investigators aim to study the effect of supplementation of CoQ10 in decreasing the incidence of contrast induced acute kidney injury in patients with acute coronary syndrome undergoing coronary angiography.
Read the detailed description
Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into 2 groups using their computer generated random numbers that group a will receive the coenzyme Q10 in addition to the standard preventive measures and group b will receive only the standard preventive measures without the coenzyme Q10.
- Conditions
- Contrast-induced Nephropathy
- Being tested
- Coenzyme Q10 100 Milligrams Oral Capsule, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10 100 Milligrams Oral CapsuleDrug
Also called Coenzyme Q10
Patients will be randomly divided into two groups using a computer generated random number chart Coenzyme Q10 group will receive 400 milligrams coenzyme Q10 preoperative and 400 milligrams coenzyme Q10 for 3 days post operative in addition to the standard preventive measures.
PlaceboDrug
placebo group will receive only the standard preventive measures (as proper hydration pre and post operative)without the coenzyme Q10.
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 100 Milligrams Oral Capsule | Experimental | Coenzyme Group received coenzyme Q10 in addition to the the standard preventive measures Receives: Drug: Coenzyme Q10 100 Milligrams Oral Capsule |
| Placebo group | Placebo comparator | Placebo Group received only the standard preventive measures Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the Creatinine rise in 1st 48-72 hours in ccu
a rise in serum creatinine of at least 0.5 mg/dL or a 25% increase from baseline within 48 to 72 hours after contrast exposure
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start15 Jun 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced NephropathyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RAMY Mohamed, Principal investigator, Resident of cardiology department,Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429345
- Sponsor's protocol ID
- MS70/2024
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Role of Coenzyme Q10 in Prevention of Contrast Induced Nephropathy in Patients With Acute Coronary Syndrome Undergoing Coronary Angiography With or Without Intervention.
- ClinicalTrials.gov ID
- NCT06429345
- Acronym / sponsor ID
- MS70/2024
- Conditions
- Contrast-induced Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 28 May 2024 (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.
In this study the investigators aim to study the effect of supplementation of CoQ10 in decreasing the incidence of contrast induced acute kidney injury in patients with acute coronary syndrome undergoing coronary angiography.
Detailed description
Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into 2 groups using their computer generated random numbers that group a will receive the coenzyme Q10 in addition to the standard preventive measures and group b will receive only the standard preventive measures without the coenzyme Q10.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 100 Milligrams Oral Capsule | Experimental | Drug: Coenzyme Q10 100 Milligrams Oral CapsuleCoenzyme Group received coenzyme Q10 in addition to the the standard preventive measures |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo Group received only the standard preventive measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 18 years or older.
- ST-elevation myocardial infarction (STEMI).
- Non ST-elevation myocardial infarction( NSTEMI).
- Unstable Angina (UA)
Key exclusion criteria (4 listed)
- Renal transplant patients.
- Preoperative bleeding .
- Intraoperative bleeding or hypotension.
- Patients taking any nephrotoxic medications
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 |
|---|---|---|
| Coenzyme Q10 100 Milligrams Oral CapsuleAlso: Coenzyme Q10Patients will be randomly divided into two groups using a computer generated random number chart Coenzyme Q10 group will receive 400 milligrams coenzyme Q10 preoperative and 400 milligrams coenzyme Q10 for 3 days post operative in addition to the standard preventive measures. | Drug | Coenzyme Q10 100 Milligrams Oral Capsule |
| Placeboplacebo group will receive only the standard preventive measures (as proper hydration pre and post operative)without the coenzyme Q10. | Drug | Placebo group |
Primary outcome
Percentage of the Creatinine rise in 1st 48-72 hours in ccu
Time frame: 48-72 hours
a rise in serum creatinine of at least 0.5 mg/dL or a 25% increase from baseline within 48 to 72 hours after contrast exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
Related trials for Contrast-induced Nephropathy
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
Not yet recruitingObservational study
An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
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.
RAMY Mohamed principal investigator
Resident of cardiology department,Ain shams university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coenzyme Q10 100 Milligrams Oral Capsule in people with Contrast-induced Nephropathy, run by Ain Shams University at 2 sites 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramy Mohamed, Resident (01002820102, 96ramymohamed22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of the Creatinine rise in 1st 48-72 hours in ccu (time frame: 48-72 hours). 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 28 Jun 2024.