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Coronary Artery Disease(CAD)NCT07306728

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

A study testing Ice Bag Application in people with Coronary Artery Disease(CAD) and Percutaneous Coronary Intervention, run by Mansoura University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ice Bag Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
20 Dec 2025to 30 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 1. 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.
  • 4. Patients with known peripheral vascular disease affecting the femoral artery.
  • 5. 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.

About this study

Official title: Effect of Femoral Region Ice Bag Application on Patients' Clinical Outcomes

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

Read the detailed description

Complications associated with PCI significantly impact patient outcomes and place substantial demands on healthcare systems. These adverse events contribute to increased morbidity and mortality rates, prolonged hospitalizations, higher healthcare expenditures, and longer 0waiting times for subsequent cardiac procedures. (Guedeney et al., 2024; Ntow, Agyeman, Aryal, \& Patel, 2024) . Postoperative pain remains a prevalent concern following PCI, particularly after femoral catheter removal, with approximately 33% of patients reporting discomfort at the access site (Al-Zuhairi \& Abed, 2024).

Although this pain typically subsides over time, it can significantly affect patient comfort and recovery in the immediate post-procedural phase. In addition to pain, hematoma formation is among the most frequent vascular complications associated with femoral artery access, with a reported prevalence of up to 15.5% (Zhi et al., 2024). These hematomas, resulting from bleeding at the puncture site, can range from minor bruising to substantial blood collections, potentially leading to pain, swelling, and further clinical complications (Hamdi, Abd El Megeed, Abd Al Ghaffare, \& Abdelmowla, 2023). Traditional pressure application remains a commonly employed strategy in clinical settings for managing such hematomas and mitigating their progression (Rodgers et al., 2025).

Cryotherapy, or cold therapy, is a well-established non-pharmacological intervention widely utilized in clinical practice to alleviate pain, reduce swelling, and control inflammation. This method typically involves the localized application of ice packs or bags, which may range from specially designed medical devices to simple waterproof plastic bags (Garcia, Karri, Zacharias, \& Abd-Elsayed, 2021). In the context of PCI care, cryotherapy has shown promise in minimizing vascular complications following femoral arterial sheath removal. The application of a cold pack to the femoral region can aid in reducing pain, controlling bleeding, and limiting hematoma formation.

The therapeutic effect is primarily attributed to the vasoconstriction induced by cold exposure, which enhances coagulation, decreases local blood flow, and increases blood viscosity (Al-Bayati \& Al-Kassar, 2023). Additionally, it decreases temperature by primarily reducing metabolic activity, which reduces inflammatory response as well as reduces nerve conductivity, thereby slowing pain impulse transmission and decreasing pain perception and tissue damage (Behera \& Shetty, 2023).

The significance of this study lies in its potential to enhance post-PCI patient care through a simple, non-pharmacological intervention. Growing evidence supports the clinical effectiveness of ice bag application in managing complications associated with femoral catheter removal. Research by )Al-Zuhairi and Abed 2024), and )Pamuk and Özkaraman 2024), confirmed that localized ice therapy significantly alleviates pain and reduces vascular complications following PCI, emphasizing its role in improving patient comfort and outcomes.

Furthermore, findings by (Suhanda Putri, and Setiawan, 2023), and (Kristiyan, Purnomo, and Ropyant 2019), demonstrated that cold pack application effectively minimizes hematoma formation, showing superiority over traditional methods such as sandbag use. While )Valikhani, Mahdizadeh, Eshraghi, Mazloum, and Dehghani, 2020), reported no statistically significant differences between cryotherapy and control groups, their findings may be attributed to shorter application durations. This variation shows how important it is to have a clear and consistent protocol, as highlighted in the randomized controlled trial by ( Sokhanvar, Tirgari, Forouzi, Salari, and Jahani, 2023), which focused on differences in how and when the cold therapy was applied.

Together, these studies highlight the need for continued research to develop standardized, evidence-based protocols for the use of ice bag application in post-PCI care. This study aims to build on existing evidence by evaluating the effectiveness of ice therapy in reducing complications and improving patient outcomes. By doing so, it seeks to promote a simple, practical, and effective method for managing common post-PCI issues-one that can be easily implemented in clinical settings to enhance recovery and increase patient satisfaction.

Being tested
Ice Bag Application
Keywords
Ice Bag Application, Clinical Outcomes, Percutaneous Coronary Intervention
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ice Bag ApplicationOther

    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

Study groups in NCT07306728
Study groupRoleWhat they receive
Ice Bag Application (IBA) GroupOtherPatients 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
Receives: Other: Ice Bag Application
• Routine Care GroupNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Level

    Assessed using a standardized pain scale

    Measured: 3 months

Secondary outcomes (1)
  1. Hematoma Formation

    Presence and size of hematoma at the puncture site, measured in centimeters using hematoma scale

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start20 Dec 2025 (estimated)
  3. Primary completion30 Mar 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07306728
Sponsor's protocol ID
29806151204272
Status last verified
Dec 2025
First submitted
14 Dec 2025
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ice Bag Application in people with Coronary Artery Disease(CAD) and Percutaneous Coronary Intervention, run by Mansoura University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Level (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

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