Effect of Femoral Region Ice Bag Application on Patients' Clinical Outcomes Post-Percutaneous Coronary Intervention

NCT07306728 | Not Yet Recruiting DMC

• 1 other identifier: 29806151204272
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Coronary artery disease (CAD) remains a leading cause of morbidity and mortality worldwide, necessitating advancements in diagnostic techniques (Parulkar et al., 2025). According to the British Heart Foundation, over 250 million individuals worldwide are living with CAD, making it the most commonly diagnosed heart condition globally. In 2021, CAD was responsible for approximately 9 million deaths, accounting for about one in every seven deaths globally

Conditions

Percutaneous Coronary Intervention; Coronary Artery Disease(CAD)

Keywords

Ice Bag Application, Clinical Outcomes, Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Pain Level

  Assessed using a standardized pain scale

  3 months

Secondary Outcomes (1)

• Hematoma Formation

  3 months

Study Arms (2)

Ice Bag Application (IBA) Group

OTHER

Patients in this group will receive localized cold therapy, consisting of an ice bag maintained at a temperature of 0-4°C, applied to the femoral region for 20 minutes with 10-minute intervals during the first two hours following PCI

Other: Ice Bag Application

• Routine Care Group

NO INTERVENTION

Patients in this group will receive standard post-PCI care as per hospital protocol, which includes the application of a sandbag to the femoral site for 20 minutes with 10-minute intervals during the first two hours following PCI.

Interventions

Ice Bag Application OTHER

cold therapy, consisting of an ice bag maintained at a temperature of 0-4°C, applied to the femoral region for 20 minutes with 10-minute intervals during the first two hours following PCI

Ice Bag Application (IBA) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Adult patients (aged 18 years and above) who have undergone elective PCI via femoral artery access.
• \. Patients who are conscious, oriented, and able to report pain level. 3. Hemodynamically stable post-procedure.

You may not qualify if:

• \. Patients with active infections 2. Patient with double femoral sheath region. 3. Patients with bleeding scar tissue from burns, wounds or hematoma in the femoral artery area before sheath removal.
• \. Patients with known peripheral vascular disease affecting the femoral artery.
• \. Allergy or contraindication to cold application. 6. Active bleeding at the access site. 7. Patients receiving anti-coagulation therapy beyond the standard post-PCI protocol.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing specialist

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: December 20, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12