Fractional Flow ReserveNCT02670005
Fractional Flow Reserve Versus Angiography for Guiding Selective Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction
An observational study of Fractional Flow Reserve and ST-segment Elevation Myocardial Infarction, run by Nanjing Medical University.
Trial summary
To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI) assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractional Flow Reserve, ST-segment Elevation Myocardial Infarction, Percutaneous Coronary Intervention
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2017
- 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: patients with ST-segment elevation myocardial infarction received selective percutaneous coronary intervention
Who may be able to join
- age>18 years
- documented acute ST-segment elevation myocardial infarction
- onset of symptom >6 days before percutaneous coronary intervention
- eligible for PCI
Who cannot join
- cardiogenic shock or hemodynamic instability
- highly tortuous or calcified arteries
- infarct related artery with a diameter < 2.5mm
- a life expectancy< 2 years
- intolerance to anti-platelet drugs
- left main disease (≥ 50% stenosis)
- contraindication to adenosine
- hypertrophic cardiomyopathy
About this study
To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI) assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous coronary intervention (PCI).
Read the detailed description
The investigators retrospectively collect STEMI patients received selective PCI from Jan 2012 to Dec 2015. Clinical follow-up is performed from the date of FFR assessment to Dec 2016 or death, which is up to 5 years. The primary endpoint is major adverse cardiac events, composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. The primary endpoints are cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established. Reinfarction is defined as myocardial infarction after the PCI procedure. Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of angina, ventricular arrhythmias and heart failure. All patients were received FFR-guided PCI or angiography-guided PCI before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.
- Conditions
- Fractional Flow Reserve, ST-segment Elevation Myocardial Infarction, Percutaneous Coronary Intervention
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FFR-PCI group | patients with ST-segment elevation myocardial infarction (STEMI) who received fractional flow reserve (FFR)-guided selective percutaneous coronary intervention (PCI) | |
| angiography-PCI group | patients with STEMI who received angiography-guided selective PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons
Measured: up to 5 years
Secondary outcomes (3)
cardiac death
All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established.
Measured: up to 5 years
reinfarction
Reinfarction is defined as myocardial infarction after the PCI procedure.
Measured: up to 5 years
unplanned hospitalization due to cardiovascular reasons
Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of angina, ventricular arrhythmias and heart failure.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractional Flow ReserveStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Geng, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670005
- Sponsor's protocol ID
- 20160010
- Status last verified
- Jan 2016
- First submitted
- 26 Jan 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Flow Reserve Versus Angiography for Guiding Selective Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02670005
- Acronym / sponsor ID
- 20160010
- Conditions
- Fractional Flow Reserve, ST-segment Elevation Myocardial Infarction, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 1 Feb 2016 (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.
To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI) assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous coronary intervention (PCI).
Detailed description
The investigators retrospectively collect STEMI patients received selective PCI from Jan 2012 to Dec 2015. Clinical follow-up is performed from the date of FFR assessment to Dec 2016 or death, which is up to 5 years. The primary endpoint is major adverse cardiac events, composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. The primary endpoints are cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established. Reinfarction is defined as myocardial infarction after the PCI procedure. Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of angina, ventricular arrhythmias and heart failure. All patients were received FFR-guided PCI or angiography-guided PCI before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR-PCI group | – | –patients with ST-segment elevation myocardial infarction (STEMI) who received fractional flow reserve (FFR)-guided selective percutaneous coronary intervention (PCI) |
| angiography-PCI group | – | –patients with STEMI who received angiography-guided selective PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with ST-segment elevation myocardial infarction received selective percutaneous coronary intervention
Key inclusion criteria (4 listed)
- age>18 years
- documented acute ST-segment elevation myocardial infarction
- onset of symptom >6 days before percutaneous coronary intervention
- eligible for PCI
Key exclusion criteria (8 listed)
- cardiogenic shock or hemodynamic instability
- highly tortuous or calcified arteries
- infarct related artery with a diameter < 2.5mm
- a life expectancy< 2 years
- intolerance to anti-platelet drugs
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
Major adverse cardiac events
Time frame: up to 5 years
composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons
3 secondary outcomes
cardiac death
Time frame: up to 5 years
reinfarction
Time frame: up to 5 years
unplanned hospitalization due to cardiovascular reasons
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractional Flow Reserve and ST-segment Elevation Myocardial Infarction, run by Nanjing Medical University.
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 8 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 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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: up to 5 years). It is what the study was designed to measure, not a finding.
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 26 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.