National Tunisian Registry of Percutaneous Coronary Intervention

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.

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Key information

Conditions

ACS - Acute Coronary Syndrome Acute Coronary Syndrome Angina Pectoris Angor Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire

Tunis, 105, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Withdrawn consent

Treatment and study plan

Primary outcomes

MACE endopoint (Major adverse cardiovascular event)

Time frame: 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 outcomes

Death

Time frame: Time-To-Event measure up to 12 months from baseline

Occurence of death incident (cardiovascular and non cardiovascular)
PCI (Percutaneous Coronary Intervention)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Dacima Consulting

Other

Collaborators

Tunisian Society of Cardiology and Cardiovascular Surgery

Registry information

Acronym: NATURE-PCI

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: Jan 7, 2020
Registry last updated: Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed