Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow

NCT06301880 | Completed Phase 3

• 1 other identifier: 3200
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Forty-six consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled. After the left IMA was harvested, free flow was measured under controlled hemodynamic conditions before any intervention (flow 1) and at a mean of 12.5 minutes after the topical application of one of three agents (milrinone, nitroglycerin or normal saline) on the IMA (flow 2).

Conditions

Internal Mammary Artery Syndrome; Vasodilation

Keywords

milrinone; graft; coronary artery bypass grafting; spasm

Outcome Measures

Primary Outcomes (1)

• LIMA free flow

  Reading the volume of blood ejected from the tip of the freely bleeding IMA through a one-minute period

  Immediately following harvesting the LIMA and 10 mintues following the topical application of the drug

Study Arms (3)

Group 1: Normal saline

PLACEBO COMPARATOR

Patients in this group were randomly assigned to receive the topical application of normal saline (0.9% sodium chloride solution) on the LIMA graft as control

Drug: The topical application of a vasodilator on the LIMA graft

Group 2: Nitroglycerin

ACTIVE COMPARATOR

Patients were randomly assigned to receive the topical application of nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline on the LIMA graft.

Drug: The topical application of a vasodilator on the LIMA graft

Group 3: milrinone

ACTIVE COMPARATOR

Patients were randomly assigned to receive the topical application of milrinone (Baxter Pharmaceuticals, Ahmedabad, India) on the LIMA graft

Drug: The topical application of a vasodilator on the LIMA graft

Interventions

The topical application of a vasodilator on the LIMA graft DRUG

Patients were randomly assigned to receive the topical application of one of three agents: milrinone (Baxter Pharmaceuticals, Ahmedabad, India) 10 mg in 20 ml of dextrose 5%, nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline, or normal saline (0.9% sodium chloride solution) as control.

Also known as: milrinone (Baxter Pharmaceuticals, Ahmedabad, India), nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran)

Group 1: Normal saline; Group 2: Nitroglycerin; Group 3: milrinone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective primary coronary artery bypass grafting

You may not qualify if:

• patients who developed ischemic events during surgery

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University Cardiac Surgery Hospital

Damascus, Syria

Location

MeSH Terms

Conditions

Aneurysm; Spasm

Interventions

Milrinone; Nitroglycerin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amrinone; Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitro Compounds

Study Officials

• Mohammad Bashar Izzat, FRCS(CTh)

  Damascus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All surgical procedures and measurements were carried out by a single surgeon (MBI) who was blinded to the topical agent which was applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: January 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data is currently and permanently available
• Access Criteria: open access

Locations

SY (1)