National Tunisian Registry of Percutaneous Coronary Intervention

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04219761

Acronym

NATURE-PCI

Enrollment

2698

Registered

2020-01-07

Start date

2020-01-30

Completion date

2022-03-30

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACS - Acute Coronary Syndrome, Angor Pectoris, Myocardial Infarction, Myocardial Ischemia

Keywords

ACS, PCI, MI

Brief summary

The National Tunisian Registry of Percutaneous Coronary Intervention is an observational, prospective and multicenter study aiming to assess coronary intervention strategies in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Tunisian patient needing PCI (Percutaneous Coronary Intervention) at the enrollment period * Informed and signed consent

Exclusion criteria

* Withdrawn consent

Design outcomes

Primary

Measure	Time frame	Description
MACE endopoint (Major adverse cardiovascular event)	Time-To-Event measure up to 12 months from baseline	Composite endpoint (MACE: major adverse cardiovascular event) : occurence of cardiovascular death, or non fatal myocardial infraction, or non fatal stroke, or Target Lesion revascularisation, or Target Vessel Revascularisation

Secondary

Measure	Time frame	Description
Death	Time-To-Event measure up to 12 months from baseline	Occurence of death incident (cardiovascular and non cardiovascular)
PCI (Percutaneous Coronary Intervention)	Time-To-Event measure up to 12 months from baseline	PCI (Percutaneous Coronary Intervention) complications: any side effect event occuring per or post cardiac intervention

Countries

Tunisia

Outcome results