Clinical trial NCT04219761: National Tunisian Registry of Percutaneous Coronary Intervention
Official title: National Tunisian Registry of Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACS - Acute Coronary Syndrome
Angor Pectoris
Myocardial Infarction
Myocardial Ischemia
Keywords: ACS
PCI
MI
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Tunisian Society of Cardiology and Cardiovascular Surgery
First posted: 2020-01-07
Enrollment: 2698
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tunisian patients needing percutaneous coronray intervention

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Withdrawn consent

Primary outcomes:
measure: MACE endopoint (Major adverse cardiovascular event)
timeFrame: Time-To-Event measure up to 12 months from baseline
Secondary outcomes:
measure: Death
timeFrame: Time-To-Event measure up to 12 months from baseline
measure: PCI (Percutaneous Coronary Intervention)
timeFrame: Time-To-Event measure up to 12 months from baseline
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire
Study officials:
affiliation: Tunisian Society of Cardiology and Cardiovascular Surgery
name: Leila Abid, MD
role: STUDY_CHAIR
affiliation: Tunisian Society of Cardiology and Cardiovascular Surgery
name: Rania Hammami, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammami R, Boudiche S, Rami T, Ben Halima N, Jamel A, Rekik B, Gribaa R, Imtinene BM, Charfeddine S, Ellouze T, Bahloul A, Hedi BS, Langar J, Ben Ahmed H, Ibn Elhadj Z, Hmam M, Ben Abdessalem MA, Maaoui S, Fennira S, Lobna L, Hassine M, Ouanes S, Mohamed Faouzi D, Mallek S, Mahdhaoui A, Meriem D, Jomaa W, Zayed S, Kateb T, Bouchahda N, Azaiez F, Ben Salem H, Marouen M, Noamen A, Abdesselem S, Hichem D, Ibn Hadj Amor H, Abdeljelil F, Amara A, Bejar K, Khaldoun BH, Hamza C, Ben Jamaa M, Fourati S, Elleuch F, Grati Z, Chtourou S, Marouene S, Sahnoun M, Hadrich M, Mohamed Abdelkader M, Bouraoui H, Kamoun K, Hadrich M, Ben Chedli T, Drissa MA, Charfeddine H, Saadaoui N, Achraf G, Ahmed S, Ayari M, Nabil M, Mnif S, Sahnoun M, Kammoun H, Ben Jemaa K, Mostari G, Hamrouni N, Yamen M, Ellouz Y, Smiri Z, Hdiji A, Bassem J, Ayadi W, Zouari A, Abbassi C, Fatma BM, Battikh K, Kharrat E, Gtif I, Sami M, Bezdah L, Kachboura S, Maatouk MF, Kraiem S, Jeridi G, Neffati E, Kammoun S, Ben Ameur Y, Fehri W, Gamra H, Zakhama L, Addad F, Mohamed Sami M, Abid L. Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study. JMIR Res Protoc. 2022 Aug 5;11(8):e24595. doi: 10.2196/24595.