National Tunisian Registry of Percutaneous Coronary Intervention

NCT ID: NCT04219761

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2698 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2022-03-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Withdrawn consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tunisian Society of Cardiology and Cardiovascular Surgery

OTHER

Sponsor Role: collaborator

Dacima Consulting

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leila Abid, MD

Role: STUDY_CHAIR

Tunisian Society of Cardiology and Cardiovascular Surgery

Rania Hammami, MD

Role: PRINCIPAL_INVESTIGATOR

Tunisian Society of Cardiology and Cardiovascular Surgery

Locations

Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire

Tunis, , Tunisia

Countries

Tunisia

References

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.

Reference Type: DERIVED

PMID: 35930353 (View on PubMed)

Other Identifiers

DAC-009-NATUREPCI

Identifier Type: -

Identifier Source: org_study_id