NCT04219761

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,698

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

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

First Submitted

Initial submission to the registry

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

January 30, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

April 4, 2022

Status Verified

April 1, 2022

Enrollment Period

1.9 years

First QC Date

January 5, 2020

Last Update Submit

April 1, 2022

Conditions

ACS - Acute Coronary SyndromeAngor PectorisMyocardial InfarctionMyocardial Ischemia

Keywords

ACSPCIMI

Outcome Measures

Primary Outcomes (1)

  • MACE endopoint (Major adverse cardiovascular event)

    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

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

Secondary Outcomes (2)

  • Death

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

  • PCI (Percutaneous Coronary Intervention)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tunisian patients needing percutaneous coronray intervention

You may qualify if:

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

You may not qualify if:

  • Withdrawn consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire

Tunis, 105, Tunisia

Location

Related Publications (1)

  • 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.

    PMID: 35930353DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeAngina PectorisMyocardial InfarctionMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • Leila Abid, MD

    Tunisian Society of Cardiology and Cardiovascular Surgery

    STUDY CHAIR

  • Rania Hammami, MD

    Tunisian Society of Cardiology and Cardiovascular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

January 30, 2020

Primary Completion

December 31, 2021

Study Completion

March 30, 2022

Last Updated

April 4, 2022

Record last verified: 2022-04

Locations

TU(1)