ACS - Acute Coronary SyndromeNATURE-PCINCT04219761
National Tunisian Registry of Percutaneous Coronary Intervention
An observational study of ACS - Acute Coronary Syndrome and Angor Pectoris, run by Dacima Consulting at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACS - Acute Coronary Syndrome, Angor Pectoris, Myocardial Infarction
- How many people
- 2,698 participants
- Where
- 1 siteTunisia
- Study dates
- 30 Jan 2020to 30 Mar 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tunisian patients needing percutaneous coronray intervention
Who may be able to join
- Tunisian patient needing PCI (Percutaneous Coronary Intervention) at the enrollment period
- Informed and signed consent
Who cannot join
- Withdrawn consent
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire
Tunis, 105
About this study
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.
- Keywords
- ACS, PCI, MI
- Medical subject headings
- Acute Coronary Syndrome, Angina Pectoris, Myocardial Infarction, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time-To-Event measure up to 12 months from baseline
Secondary outcomes (2)
Death
Occurence of death incident (cardiovascular and non cardiovascular)
Measured: Time-To-Event measure up to 12 months from baseline
PCI (Percutaneous Coronary Intervention)
PCI (Percutaneous Coronary Intervention) complications: any side effect event occuring per or post cardiac intervention
Measured: Time-To-Event measure up to 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start30 Jan 2020
- Primary completion31 Dec 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACS - Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,698 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Tunisian Society of Cardiology and Cardiovascular Surgery
- Responsible party
- Sponsor
- Investigators
- Leila Abid, MD, Study chair, Tunisian Society of Cardiology and Cardiovascular SurgeryRania Hammami, MD, Principal investigator, Tunisian Society of Cardiology and Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219761
- Sponsor's protocol ID
- DAC-009-NATUREPCI
- Acronym
- NATURE-PCI
- Status last verified
- Apr 2022
- First submitted
- 5 Jan 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35930353
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Tunisian Registry of Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04219761
- Acronym / sponsor ID
- NATURE-PCI / DAC-009-NATUREPCI
- Keywords
- ACS, PCI, MI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,698 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Tunisian Society of Cardiology and Cardiovascular Surgery
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tunisian patients needing percutaneous coronray intervention
Key inclusion criteria (2 listed)
- Tunisian patient needing PCI (Percutaneous Coronary Intervention) at the enrollment period
- Informed and signed consent
Key exclusion criteria (1 listed)
- Withdrawn consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Death
Time frame: Time-To-Event measure up to 12 months from baseline
PCI (Percutaneous Coronary Intervention)
Time frame: Time-To-Event measure up to 12 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Derived from this study: PubMed 35930353Hammami 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.
- Individual participant dataSharing planned: Undecided
Related trials for ACS - Acute Coronary Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila Abid, MD study chair
Tunisian Society of Cardiology and Cardiovascular Surgery
Rania Hammami, MD principal investigator
Tunisian Society of Cardiology and Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACS - Acute Coronary Syndrome and Angor Pectoris, run by Dacima Consulting at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE endopoint (Major adverse cardiovascular event) (time frame: Time-To-Event measure up to 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04219761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.