Functional Evaluation of Non Culprit Lesions in ACS PatientsFORECASTNCT01671631
The Diastolic Pressure Gradient for Patients With Acute Coronary Syndrome: Evaluation of Non Culprit Lesions
An observational study of Functional Evaluation of Non Culprit Lesions in ACS Patients, run by University Magna Graecia at 1 site in Italy.
Trial summary
The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration is currently required for functional evaluation of stenosis severity using the fractional flow reserve (FFR). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Functional Evaluation of Non Culprit Lesions in ACS Patients
- What is being tested?
- Measurement of intracoronary pressure
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Acute Coronary Syndrome and multivessel coronary artery disease.
Who may be able to join
- age 40 to 80 years
- recent Acute Coronary Syndrome
- indication for coronary angiography
- presence of at least one non-culprit lesion requiring functional evaluation with fractional flow reserve (FFR):
Who cannot join
- Haemodynamically significant valvular disease
- controindication for Adenosin administration
- previous CABG on the index vessel
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cardiologia Interventistica UMG
Catanzaro, Calabria, 88100
Ciro Indolfi, Prof., +3909613647067, clinicaltrials-cardioumg@email.it
Ciro Indolfi, MD
About this study
The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration is currently required for functional evaluation of stenosis severity using the fractional flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the instantaneous wave-free ratio (iFR), was recently introduced.
Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow reserve (FFR) in ACS patients.
- Being tested
- Measurement of intracoronary pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of intracoronary pressureOther
| Study group | Role | What they receive |
|---|---|---|
| Acute Coronary Syndrome | Patients with Acute Coronary Syndrome and multivessel coronary artery disease undergoing functional evaluation of non-culprit lesions. Receives: Other: Measurement of intracoronary pressure |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Evaluation of Non Culprit Lesions in ACS PatientsStudies 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
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciro Indolfi, University Magna Graecia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671631
- Sponsor's protocol ID
- FORECAST
- Acronym
- FORECAST
- Status last verified
- Aug 2012
- First submitted
- 20 Aug 2012
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diastolic Pressure Gradient for Patients With Acute Coronary Syndrome: Evaluation of Non Culprit Lesions
- ClinicalTrials.gov ID
- NCT01671631
- Acronym / sponsor ID
- FORECAST / FORECAST
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- First posted
- 23 Aug 2012 (estimated)
- 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 assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration is currently required for functional evaluation of stenosis severity using the fractional flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the instantaneous wave-free ratio (iFR), was recently introduced.
Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow reserve (FFR) in ACS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Syndrome | – | Other: Measurement of intracoronary pressurePatients with Acute Coronary Syndrome and multivessel coronary artery disease undergoing functional evaluation of non-culprit lesions. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Acute Coronary Syndrome and multivessel coronary artery disease.
Key inclusion criteria (4 listed)
- age 40 to 80 years
- recent Acute Coronary Syndrome
- indication for coronary angiography
- presence of at least one non-culprit lesion requiring functional evaluation with fractional flow reserve (FFR):
Key exclusion criteria (3 listed)
- Haemodynamically significant valvular disease
- controindication for Adenosin administration
- previous CABG on the index vessel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of intracoronary pressure | Other | Acute Coronary Syndrome |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Web site, Division of Cardiology at Magna graecia UniversityLink provided by the sponsor.
- Web site, Dipartimento di Scienze Mediche e Chirurgiche, Magna Graecia UniversityLink provided by the sponsor.
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.
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 Functional Evaluation of Non Culprit Lesions in ACS Patients, run by University Magna Graecia at 1 site in Italy.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Aug 2012. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ciro Indolfi, Prof (+3909613647067, clinicaltrials-cardioumg@email.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 23 Aug 2012.