Coronary Artery DiseasePOST-ITNCT01835808
Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease
An observational study of Coronary Artery Disease, run by Portuguese Society of Cardiology at 1 site in Portugal.
Trial summary
Functional evaluation of coronary lesions, through the evaluation of fractional flow reserve (FFR) with pressure-wire in patients with coronary artery disease (CAD) was evaluated in a randomised trial - the FAME trial - where it was showed to be superior to classic anatomical evaluation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Fractional flow reserve (St. Jude Medical pressure-wire)
- Type of treatment
- Medical device
- How many people
- 918 participants
- Where
- 1 sitePortugal
- Study dates
- Mar 2012to Nov 2014
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation).
Who may be able to join
- consecutive CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation).
Who cannot join
- Patient not willing to participate (informed consent not signed).
- Life expectancy lower than 12 months (due to cardiac or non-cardiac disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of the Evaluation of FFR in the Treatment of Coronary Artery Disease
Functional evaluation of coronary lesions, through the evaluation of fractional flow reserve (FFR) with pressure-wire in patients with coronary artery disease (CAD) was evaluated in a randomised trial - the FAME trial - where it was showed to be superior to classic anatomical evaluation. Based on these results, current guidelines recommend the use of FFR (class I-A recommendation) when objective evidence of vessel-related ischemia is not available. Since the FAME trial was published, FFR use increased dramatically in most European countries, Portugal being no exception to this trend. FFR is currently being used in many interventional cardiology centres quite beyond the European Guidelines recommendation, since many physicians now trust more on the information they can collect with pressure-wire during the angiography, and less on non invasive imaging stress tests.
Considering this widespread use of FFR in the evaluation of patients with CAD, there is a need to clarify the clinical results of this approach in a "real patient setting". The Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT) was planned to evaluate if the use of FFR in the decision of coronary revascularization is feasible and allows optimized clinical results in "real world" non selected patients, as showed in clinical randomised trials.
Read the detailed description
Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT9 is a national multicentric, prospective, consecutive (non selected) anonymous observational study of all patients submitted to coronary angiography and in which functional evaluation with pressure-wire of coronary lesions is to be performed. The main purpose of the registry is to collect data on the medical decisions and clinical results in CAD patients evaluated with FFR (using pressure-wire®, St. Jude Medical), in order to provide evidence in "real world" non selected patients. This evidence will add to the already available clinical data from randomized trials. All Portuguese interventional cardiology centers performing regularly FFR studies were invited to participate in the study. Data will be collected at the time of the procedure and patients will be clinically followed-up for 1 year. Information concerning medical history, past exams, the angiography, the FFR study and the follow-up will be collected on registry forms. The treatment strategy for each patient will be decided by the operator physician, according to his best clinical judgment. Changes in treatment strategy due to FFR results will be recorded, but the intention of the study is just to collect clinical information, and not to influence physician practice. An informed consent form must be signed for all patients included. Patients will be free to withdraw this consent at anytime.
- Conditions
- Coronary Artery Disease
- Being tested
- Fractional flow reserve (St. Jude Medical pressure-wire)
- Keywords
- Fractional flow reserve
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional flow reserve (St. Jude Medical pressure-wire)Device
Also called Pressure-Wire (St. Jude Medical)
CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation)
| Study group | Role | What they receive |
|---|---|---|
| Fractional Flow Reserve | Coronary artery disease patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation). Receives: Device: Fractional flow reserve (St. Jude Medical pressure-wire) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Combined endpoint of major adverse cardiac events (cardiovascular mortality, myocardial infarction and coronary revascularization)
Measured: One Year
Secondary outcomes (3)
Cardiovascular mortality
Cardiovascular mortality at one year
Measured: One Year
Myocardial infarction
Rate of Myocardial infarction at one year
Measured: One year
Coronary revascularization
Unplanned coronary revascularization at one year
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startMar 2012
- Primary completionNov 2013
- Study completionNov 2014
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 Coronary Artery DiseaseStudies 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
- 918 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Portuguese Society of Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Portuguese Association of Interventional Cardiology, Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Sergio B Baptista, MD, Principal investigator, Hospital Fernando Fonseca, Amadora, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835808
- Sponsor's protocol ID
- POST-IT
- Acronym
- POST-IT
- Status last verified
- May 2015
- First submitted
- 16 Apr 2013
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baptista SB, Raposo L, Santos L, Ramos R, Cale R, Jorge E, Machado C, Costa M, Infante de Oliveira E, Costa J, Pipa J, Fonseca N, Guardado J, Silva B, Sousa MJ, Silva JC, Rodrigues A, Seca L, Fernandes R. Impact of Routine Fractional Flow Reserve Evaluation During Coronary Angiography on Management Strategy and Clinical Outcome: One-Year Results of the POST-IT. Circ Cardiovasc Interv. 2016 Jul;9(7):e003288. doi: 10.1161/CIRCINTERVENTIONS.115.003288.
PubMed 27412867
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Evaluation of FFR in the Treatment of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01835808
- Acronym / sponsor ID
- POST-IT / POST-IT
- Conditions
- Coronary Artery Disease
- Keywords
- Fractional flow reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 918 participants (actual)
- Lead sponsor
- Portuguese Society of CardiologyUniversity, hospital or other
- Collaborators
- Portuguese Association of Interventional Cardiology, Abbott Medical Devices
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Apr 2013 (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.
Functional evaluation of coronary lesions, through the evaluation of fractional flow reserve (FFR) with pressure-wire in patients with coronary artery disease (CAD) was evaluated in a randomised trial - the FAME trial - where it was showed to be superior to classic anatomical evaluation. Based on these results, current guidelines recommend the use of FFR (class I-A recommendation) when objective evidence of vessel-related ischemia is not available. Since the FAME trial was published, FFR use increased dramatically in most European countries, Portugal being no exception to this trend. FFR is currently being used in many interventional cardiology centres quite beyond the European Guidelines recommendation, since many physicians now trust more on the information they can collect with pressure-wire during the angiography, and less on non invasive imaging stress tests.
Considering this widespread use of FFR in the evaluation of patients with CAD, there is a need to clarify the clinical results of this approach in a "real patient setting". The Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT) was planned to evaluate if the use of FFR in the decision of coronary revascularization is feasible and allows optimized clinical results in "real world" non selected patients, as showed in clinical randomised trials.
Detailed description
Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT9 is a national multicentric, prospective, consecutive (non selected) anonymous observational study of all patients submitted to coronary angiography and in which functional evaluation with pressure-wire of coronary lesions is to be performed. The main purpose of the registry is to collect data on the medical decisions and clinical results in CAD patients evaluated with FFR (using pressure-wire®, St. Jude Medical), in order to provide evidence in "real world" non selected patients. This evidence will add to the already available clinical data from randomized trials. All Portuguese interventional cardiology centers performing regularly FFR studies were invited to participate in the study. Data will be collected at the time of the procedure and patients will be clinically followed-up for 1 year. Information concerning medical history, past exams, the angiography, the FFR study and the follow-up will be collected on registry forms. The treatment strategy for each patient will be decided by the operator physician, according to his best clinical judgment. Changes in treatment strategy due to FFR results will be recorded, but the intention of the study is just to collect clinical information, and not to influence physician practice. An informed consent form must be signed for all patients included. Patients will be free to withdraw this consent at anytime.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional Flow Reserve | – | Device: Fractional flow reserve (St. Jude Medical pressure-wire)Coronary artery disease patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation).
Key inclusion criteria (1 listed)
- consecutive CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation).
Key exclusion criteria (2 listed)
- Patient not willing to participate (informed consent not signed).
- Life expectancy lower than 12 months (due to cardiac or non-cardiac disease)
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 |
|---|---|---|
| Fractional flow reserve (St. Jude Medical pressure-wire)Also: Pressure-Wire (St. Jude Medical)CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation) | Device | Fractional Flow Reserve |
Primary outcome
Major adverse cardiac events
Time frame: One Year
Combined endpoint of major adverse cardiac events (cardiovascular mortality, myocardial infarction and coronary revascularization)
3 secondary outcomes
Cardiovascular mortality
Time frame: One Year
Myocardial infarction
Time frame: One year
Coronary revascularization
Time frame: One year
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 25 May 2015.
- Derived from this study: PubMed 27412867Baptista SB, Raposo L, Santos L, Ramos R, Cale R, Jorge E, Machado C, Costa M, Infante de Oliveira E, Costa J, Pipa J, Fonseca N, Guardado J, Silva B, Sousa MJ, Silva JC, Rodrigues A, Seca L, Fernandes R. Impact of Routine Fractional Flow Reserve Evaluation During Coronary Angiography on Management Strategy and Clinical Outcome: One-Year Results of the POST-IT. Circ Cardiovasc Interv. 2016 Jul;9(7):e003288. doi: 10.1161/CIRCINTERVENTIONS.115.003288.
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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.
Sergio B Baptista, MD principal investigator
Hospital Fernando Fonseca, Amadora, Portugal
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 Coronary Artery Disease, run by Portuguese Society of Cardiology at 1 site in Portugal.
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 1 inclusion and 2 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 25 May 2015. 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 Portugal. 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?
Major adverse cardiac events (time frame: One Year). 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 NCT01835808, 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 25 May 2015; AzTrials last refreshed its copy on 7 Nov 2026.