Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients.

June 27, 2024 updated by: Ain Shams University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospitals
        • Contact:
          • Ain shams University
      • Cairo, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coenzyme Q10 100 Milligrams Oral Capsule
Coenzyme Group received coenzyme Q10 in addition to the the standard preventive measures
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.
Other Names:
  • Coenzyme Q10
Placebo Comparator: Placebo group
Placebo Group received only the standard preventive measures
Drug: Placebo
placebo group will receive only the standard preventive measures (as proper hydration pre and post operative)without the coenzyme Q10.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: RAMY Mohamed, Resident of cardiology department,Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS70/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contrast-induced Nephropathy

Clinical Trials on Coenzyme Q10 100 Milligrams Oral Capsule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe