Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients.
Possible Role of Coenzyme Q10 in Prevention of Contrast Induced Nephropathy in Patients With Acute Coronary Syndrome Undergoing Coronary Angiography With or Without Intervention.
1 other identifier
interventional
250
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2024
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
May 28, 2024
CompletedStudy Start
First participant enrolled
June 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedJune 28, 2024
March 1, 2024
4 months
March 19, 2024
June 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
48-72 hours
Study Arms (2)
Coenzyme Q10 100 Milligrams Oral Capsule
EXPERIMENTALCoenzyme Group received coenzyme Q10 in addition to the the standard preventive measures
Placebo group
PLACEBO COMPARATORPlacebo Group received only the standard preventive measures
Interventions
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.
placebo group will receive only the standard preventive measures (as proper hydration pre and post operative)without the coenzyme Q10.
Eligibility Criteria
You may qualify if:
- Patients who are 18 years or older.
- ST-elevation myocardial infarction (STEMI).
- Non ST-elevation myocardial infarction( NSTEMI).
- Unstable Angina (UA)
You may not qualify if:
- Renal transplant patients.
- Preoperative bleeding .
- Intraoperative bleeding or hypotension.
- Patients taking any nephrotoxic medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ain Shams university hospitals
Cairo, Egypt
Ramy Mohamed Mostafa
Cairo, Egypt
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
RAMY Mohamed
Resident of cardiology department,Ain shams university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2024
First Posted
May 28, 2024
Study Start
June 15, 2024
Primary Completion
October 1, 2024
Study Completion
November 1, 2024
Last Updated
June 28, 2024
Record last verified: 2024-03