NCT07830784

Brief Summary

This single-center pilot randomized trial evaluated the safety and feasibility of same-day discharge (within 6 hours) compared with conventional overnight hospitalization (≥24 hours) in patients with chronic coronary artery disease undergoing successful elective transradial PCI in a Brazilian public tertiary center. Participants were followed by structured telemedicine consultation at 7 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 10, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

same-day dischargetransradial accesselective PCItelemedicinepublic healthcare system

Outcome Measures

Primary Outcomes (1)

  • Composite of major adverse clinical events

    All-cause death, myocardial infarction, unplanned revascularization, stroke, hospital readmission, or major bleeding (BARC ≥3)

    7 days after PCI

Secondary Outcomes (3)

  • Emergency department visits

    7 days after PCI

  • Recurrent chest pain

    7 days after PCI

  • Radial access-site complications

    7 days after PCI

Study Arms (2)

Same-Day Discharge

EXPERIMENTAL

discharge within 6 h after successful elective transradial PCI, with 7-day telemedicine follow-up.

Behavioral: same day discharge

Conventional Hospitalization

ACTIVE COMPARATOR

overnight stay ≥24 h per institutional protocol.

Behavioral: Conventional Hospitalization

Interventions

discharge within 6 h after successful elective transradial PCI, with 7-day telemedicine follow-up.

Same-Day Discharge

overnight stay ≥24 h per institutional protocol.

Conventional Hospitalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 with chronic CAD undergoing successful elective transradial PCI; written informed consent.

You may not qualify if:

  • LVEF ≤40%; MI within 14 days; creatinine clearance ≤45 mL/min; hemoglobin ≤10 g/dL; platelets ≤100,000/µL; INR \>1.5; allergy to aspirin, clopidogrel, or iodinated contrast; procedural (angiographic or clinical) complications; access-site complications requiring prolonged monitoring.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROCAPE

Recife, Pernambuco, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Audes D Feitosa, PhD

    University of Pernambuco

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 21, 2026

Study Start

July 4, 2025

Primary Completion

December 29, 2025

Study Completion

December 29, 2025

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data available upon reasonable request, subject to approval by the institutional research ethics committee (CEP HUOC/PROCAPE, cep\_huoc.procape@upe.br); requests to the ethics committee, not to a single author.

Locations