## Protocol Section
### Identification Module
**NCT ID:** NCT06429345

**Brief Title:** Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients.

**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.

#### Organization Study ID Info
**ID:** MS70/2024
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-11-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-19
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**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.

**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 Module

**Conditions:**

- Contrast-induced Nephropathy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 250

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Coenzyme Group received coenzyme Q10 in addition to the the standard preventive measures

**Intervention Names:**

- Drug: Coenzyme Q10 100 Milligrams Oral Capsule

**Label:** Coenzyme Q10 100 Milligrams Oral Capsule

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo Group received only the standard preventive measures

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Coenzyme Q10 100 Milligrams Oral Capsule

**Description:** 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.

**Name:** Coenzyme Q10 100 Milligrams Oral Capsule

**Other Names:**

- Coenzyme Q10

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo group

**Description:** placebo group will receive only the standard preventive measures (as proper hydration pre and post operative)without the coenzyme Q10.

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Percentage of the Creatinine rise in 1st 48-72 hrs in ccu

**Time Frame:** 48-72 hrs

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 96ramymohamed22@gmail.com

**Name:** Ramy Mohamed, Resident

**Phone:** 01002820102

**Role:** CONTACT

**Contact 2:**

**Email:** 96ramymohamed22@gmail.com

**Name:** Ramy Mohamed mostafa, Resident

**Phone:** 01002820102

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cairo

**Contacts:**

***Contact 1:***

- **Email:** 96ramymohamed22@gmail.com

- **Name:** Ramy Mostafa, Resident

- **Phone:** 01002820102

- **Role:** CONTACT

***Contact 2:***

- **Email:** 96ramymohamed22@gmail.com

- **Name:** Ramy Mohamed Mostafa, Resident

- **Phone:** 01002820102

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Ramy Mohamed Mostafa

#### Overall Officials

**Official 1:**

**Affiliation:** Resident of cardiology department,Ain shams university

**Name:** RAMY Mohamed

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Nephropathy

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M27545

- Name: Acute Coronary Syndrome

- Relevance: HIGH

- As Found: Acute Coronary Syndrome

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000054058

- Term: Acute Coronary Syndrome

### Intervention Browse Module - Ancestors

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014815

- Term: Vitamins

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M17201

- Name: Ubiquinone

- Relevance: HIGH

- As Found: Levofloxacin

- ID: M271049

- Name: Coenzyme Q10

- Relevance: HIGH

- As Found: Degenerative

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: T383

- Name: Coenzyme Q10

- Relevance: HIGH

- As Found: Degenerative

### Intervention Browse Module - Meshes

- ID: D000014451

- Term: Ubiquinone

- ID: C000024989

- Term: Coenzyme Q10

### Misc Info Module

- Version Holder: 2024-05-31
