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.
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
- Conditions the study is for
- Coronary Artery Disease(CAD), Percutaneous Coronary Intervention
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Assessed using a standardized pain scale
Measured: 3 months
Secondary outcomes (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.
- First posted29 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease(CAD)Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Abdeltawab Abdelmoneim Hussein Glalah, Mansoura University
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Femoral Region Ice Bag Application on Patients' Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07306728
- Acronym / sponsor ID
- 29806151204272
- Keywords
- Ice Bag Application, Clinical Outcomes, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice Bag Application (IBA) Group | Other | Other: Ice Bag ApplicationPatients 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 |
| • 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice Bag Applicationcold 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 (IBA) Group |
Primary outcome
Pain Level
Time frame: 3 months
Assessed using a standardized pain scale
1 secondary outcome
Hematoma Formation
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
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.