ClinicalTrials.gg
RecruitingNCT05051917ITACAUpdated Feb 23, 2024

The Italian Coronary Artery Aneurysm and Ectasia In Patients With Acute Coronary Syndrome

An observational study in Acute Coronary Syndrome, Angiographic Evidence if Coronary Aneurysms and Ectasia, sponsored by Federico II University. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Federico II University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Sep 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

The ITACA study is a prospective, observational no profit registry enrolling patients with Acute Coronary Syndrome and angiographic evidence of coronary aneurysms and/or ectasia.

Read the detailed description

The ITACA study is aimed at evaluating short and long term outcomes in patients with acute coronary sindrome and angiographic evidence of coronary aneurysm and/or actasia. Data regarding safety and effectiveness of invasive and pharmacological treatment strategies will be also collected.

02

Conditions studied

  • Acute Coronary Syndrome
  • Angiographic Evidence if Coronary Aneurysms
  • Ectasia

Keywords

  • Aute Coronary Syndrome
  • Coronary Artery Artery
  • Ectasia
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's planned enrollment of 500 is close to the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients undergoing coronary angiography with diagnosis of ACS and contextual detection of coronary ectasia or aneurysm in accordance with the definitions specified below. Patients with coronary pseudoaneurysms are excluded.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signature of ;
  • Patients aged ≥18 years;
  • diagnosis of ACS (ST-elevation myocardial infarction, non ST-elevation myocardial infarction, unstable angina), in accordance with the definition provided in the latest guidelines;
  • diagnosis of ectasia or coronary aneurysm according to the definitions contained in this protocol, either in the culprit vessel of the SCA than in another vessel. Coronary pseudoaneurysms are excluded.

Exclusion criteria

Exclusion Criteria:

  • impossibility or unwillingness to provide signed ;
  • to dual antiplatelet therapy;
  • contraindications to anticoagulant therapy;
  • active bleeding or severe anemia ( \<6 g / dl);
  • \<12 months;
  • female patients with potential pregnancy;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Major adverse cardiac events

    A composite endpoint of myocardial infarction, stroke, cardiovascular death, myocardial revascularization and hospitalisation due to cardiovascular events

    Time frame: two years

07

Study locations

2 of 2 sites recruiting
  • Giuseppe Tarantino
    Forlì, FC 47121, Italy
    Recruiting
  • Professor Giovanni Esposito
    Naples, 80131, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2021 (actual). Primary completion is estimated for Sep 2024, 36 months after the start.

Of 243 non-industry observational studies under Acute Coronary Syndrome, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 36 months is close to that.

Counting every sponsor, half of 277 studies reached it within 35 months; a quarter within 18 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2021
First posted
Sep 21, 2021
StartActual
Sep 1, 2021
Primary completionEst.
Sep 1, 2024
CompletionEst.
Sep 1, 2026
Last update
Feb 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05051917
Collaborators
Fondazione GISE Onlus
Responsible party
Giovanni Esposito (Professor of Cardiology, Federico II University) — Principal investigator
First posted
Sep 21, 2021
Start date
Sep 1, 2021
Primary completion
Sep 1, 2024 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Feb 23, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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