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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06429345
Other study ID # MS70/2024
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2024
Est. completion date November 1, 2024

Study information

Verified date March 2024
Source Ain Shams University
Contact Ramy Mohamed, Resident
Phone 01002820102
Email 96ramymohamed22@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date November 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who are 18 years or older. - ST-elevation myocardial infarction (STEMI). - Non ST-elevation myocardial infarction( NSTEMI). - Unstable Angina (UA) Exclusion Criteria: - Renal transplant patients. - Preoperative bleeding . - Intraoperative bleeding or hypotension. - Patients taking any nephrotoxic medications

Study Design


Intervention

Drug:
Coenzyme Q10 100 Milligrams Oral Capsule
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
placebo group will receive only the standard preventive measures (as proper hydration pre and post operative)without the coenzyme Q10.

Locations

Country Name City State
Egypt Ramy Mohamed Mostafa Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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