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Distal Transradial Access for Primary PCI in STEMI Patients to Prevent RAO (RAPIDIII)

Primary Purpose

ST Segment Elevation Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
distal radial artery
proximal radial aretry
Sponsored by
Beijing Luhe Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ST Segment Elevation Myocardial Infarction focused on measuring distal radial artey, radial artery occlusion, proximal radial artery, primary percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • ST-segment elevation myocardial infarction for primary percuteous coronary intervention
  • Palpable pulses on both access sites of the radial artery
  • Informed consent

Exclusion Criteria:

  • Thrombolysis before primary percutaneous coronary intervention
  • Previous CABG or radio-cephalic fistula using radial artery
  • Cardiogenic shock
  • Severe arrhythmias
  • Severe liver and kidney dysfunction
  • Pregnancy
  • Enrolment in another study within 1 month
  • Inability to obtain written informed consent

Sites / Locations

  • Beijing Luhe hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

distal radial artery

proximal radial artery

Arm Description

Distal radial aretry for primary percutaneous coronary intervention in STEMI patients

Proximal radial aretry for primary percutaneous coronary intervention in STEMI patients

Outcomes

Primary Outcome Measures

radial artery occlusion
The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.

Secondary Outcome Measures

the rate of successful puncture
Successful puncture occurs when an introducer sheath can be properly placed through the punctured artery.
puncture time
The puncture time was defined as the time interval between local anesthesia induction and successful sheath insertion.
first medical contact to device (FMC2D) time
FMC2D time was defined as the time interval between the patient's initial contact with the first physician who made the diagnosis and the first angioplasty balloon inflation.
procedural time
Procedural time defined as the time interval between local anesthesia to sheath removal.
hemostasis time
Hemostasis time was defined as the time between sheath removal to complete hemostasis.
access-related complications
Access-related complications include AV fistula formation, pseudoaneurysm, and local haematoma.
hand function
Hand function was evaluated by QuickDASH questionnaire.
radial artery occlusion
The radial artery occlusion will be evaluated 1 month after procedure by ultrasound.
radial aretry injury
Radial aretry injury including intimal tears, dissections, perforation and thrombosis was detected by optical coherence tomography.
major adverse cardiovascular events(MACE)
MACE was defined as all-cause death, any myocardial infarction, stroke and major bleeding.

Full Information

First Posted
July 14, 2022
Last Updated
July 14, 2022
Sponsor
Beijing Luhe Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05461781
Brief Title
Distal Transradial Access for Primary PCI in STEMI Patients to Prevent RAO
Acronym
RAPIDIII
Official Title
Distal TransRAdial Access for Primary Percutaneous Coronary Intervention in STEMI Patients to Prevent Acute Radial Artery Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Luhe Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Randomized-controlled trial to comparison of early radial artery occlusion via distal vs proximal radial artery among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.
Detailed Description
Proximal radial artery (PRA) is recommend as the default approach for patients undergoing percutaneous coronary intervention (PCI) according 2018 ESC guidelines. However, radial artery occlusion(RAO) remains the frequent complication, precluding the future use of radial artery as access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction(STEMI) presents multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of radial artery is crucial for STEMI patients. Distal radial artery(DRA), located in anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with PRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24h via DRA when compared PRA among STEMI patients for primary PCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Segment Elevation Myocardial Infarction
Keywords
distal radial artey, radial artery occlusion, proximal radial artery, primary percutaneous coronary intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, open-label, parallel randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
512 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
distal radial artery
Arm Type
Experimental
Arm Description
Distal radial aretry for primary percutaneous coronary intervention in STEMI patients
Arm Title
proximal radial artery
Arm Type
Active Comparator
Arm Description
Proximal radial aretry for primary percutaneous coronary intervention in STEMI patients
Intervention Type
Procedure
Intervention Name(s)
distal radial artery
Intervention Description
primary percutaneous coronary intervention via distal radial aretry
Intervention Type
Procedure
Intervention Name(s)
proximal radial aretry
Intervention Description
primary percutaneous coronary intervention via proximal radial aretry
Primary Outcome Measure Information:
Title
radial artery occlusion
Description
The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.
Time Frame
at 24 hours after procedure
Secondary Outcome Measure Information:
Title
the rate of successful puncture
Description
Successful puncture occurs when an introducer sheath can be properly placed through the punctured artery.
Time Frame
Immediately post-procedurally
Title
puncture time
Description
The puncture time was defined as the time interval between local anesthesia induction and successful sheath insertion.
Time Frame
Immediately post-procedurally
Title
first medical contact to device (FMC2D) time
Description
FMC2D time was defined as the time interval between the patient's initial contact with the first physician who made the diagnosis and the first angioplasty balloon inflation.
Time Frame
Immediately post-procedurally
Title
procedural time
Description
Procedural time defined as the time interval between local anesthesia to sheath removal.
Time Frame
Immediately post-procedurally
Title
hemostasis time
Description
Hemostasis time was defined as the time between sheath removal to complete hemostasis.
Time Frame
at 24 hours after procedure
Title
access-related complications
Description
Access-related complications include AV fistula formation, pseudoaneurysm, and local haematoma.
Time Frame
at 24 hours after procedure
Title
hand function
Description
Hand function was evaluated by QuickDASH questionnaire.
Time Frame
1 week after procedure
Title
radial artery occlusion
Description
The radial artery occlusion will be evaluated 1 month after procedure by ultrasound.
Time Frame
30days after procedure
Title
radial aretry injury
Description
Radial aretry injury including intimal tears, dissections, perforation and thrombosis was detected by optical coherence tomography.
Time Frame
Immediately post-procedurally
Title
major adverse cardiovascular events(MACE)
Description
MACE was defined as all-cause death, any myocardial infarction, stroke and major bleeding.
Time Frame
30 days after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years ST-segment elevation myocardial infarction for primary percuteous coronary intervention Palpable pulses on both access sites of the radial artery Informed consent Exclusion Criteria: Thrombolysis before primary percutaneous coronary intervention Previous CABG or radio-cephalic fistula using radial artery Cardiogenic shock Severe arrhythmias Severe liver and kidney dysfunction Pregnancy Enrolment in another study within 1 month Inability to obtain written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jincheng Guo
Phone
+8613521968844
Email
Guojcmd@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jincheng Guo
Organizational Affiliation
Beijing Luhe Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Luhe hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jincheng Guo, M.D.
Phone
8610-69543901
Ext
6920
Email
guojcmd@126.com

12. IPD Sharing Statement

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Distal Transradial Access for Primary PCI in STEMI Patients to Prevent RAO

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