CLINICAL TRIAL

post-PCI FFR for Myocardial Ischemia

Recruiting · 18+ · All Sexes · Quebec, Canada

This study is evaluating whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events than standard angiographic guidance.

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About the trial for Myocardial Ischemia

Eligible Conditions
Myocardial Ischemia · Angina, Stable · Unstable Angina Pectoris · Coronary Disease · Heart Diseases · Ischemic Heart Disease · Angina, Unstable · Angina Pectoris · Stable Angina (SA) · Coronary Artery Disease · Chest Pain

Treatment Groups

This trial involves 2 different treatments. Post-PCI FFR is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
post-PCI FFR
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
All treated lesions stented with drug-eluting stents (except side-branches of bifurcations)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: within 12 months after index PCI;
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: within 12 months after index PCI;.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether post-PCI FFR will improve 2 primary outcomes and 6 secondary outcomes in patients with Myocardial Ischemia. Measurement will happen over the course of Post-randomization after stent implantation (< 1 hour).

Final post-PCI pressure ratio values according to lesion location and intervened vessels
POST-RANDOMIZATION AFTER STENT IMPLANTATION (< 1 HOUR)
In the Physiology group, final pressure ratio (Pd/Pa) values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
Final post-PCI physiology pullback curves according to lesion location and intervened vessels
POST-RANDOMIZATION AFTER STENT IMPLANTATION (< 1 HOUR)
In the Physiology group, final physiology pullback curves will be collected immediately after randomization, and if further intervention is performed, before completing the intervention if possible. Physiology pullback refers to either hyperemic or non-hyperemic pullback.
Final post-PCI dPR values according to lesion location and intervened vessels
POST-RANDOMIZATION AFTER STENT IMPLANTATION (< 1 HOUR)
In the Physiology group, final dPR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
Final post-PCI FFR values according to lesion location and intervened vessels
POST-RANDOMIZATION AFTER STENT IMPLANTATION (< 1 HOUR)
In the Physiology group, final FFR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
Rate of angina-related events
WITHIN 12 MONTHS AFTER INDEX PCI;
defined as hospitalization for unstable angina and unsolicited medical visits for angina
Rate of Target Vessel Failure
WITHIN 12 MONTHS AFTER INDEX PCI;
as the composite of cardiac death, lesion-related MI and target vessel revascularization
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Who is running the study

Principal Investigator
O. F. B.
Olivier F. Bertrand, Study Principal Investigator
Laval University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of myocardial ischemia?

The presence of symptoms of myocardial ischemia has substantial diagnostic implications. In addition to standard ECG interpretation, a clinical examination may reveal evidence of left ventricular dysfunction and chest pain, both of which have significant prognostic implications.

Anonymous Patient Answer

How many people get myocardial ischemia a year in the United States?

About 3.5 million people have a cardiovascular event in a year in the United States, including an ischemic event, a heart attack, or a stroke. Around 2.8 million of these events result from a disease process other than coronary artery disease (CAD). In men, coronary heart disease was a major cause of CAD when other risk factors are accounted for. Cardiovascular events accounted for 26.3% (1.9 million) of all deaths in the United States in 1997.

Anonymous Patient Answer

What is myocardial ischemia?

The word 'ischemia' seems to come from the root word 'to dry,' because myocardial infarction (MI) is the event of myocardial ischemia. (There is no direct medical or scientific definition for 'ischemia' that is related to heart-related diseases.) Myocardial ischemia occurs when blood doesn't get enough oxygen to the heart. It is usually defined as a cardiac emergency as ICD and percutaneous coronary intervention are the only treatments for myocardial ischemia. For the rest of the article, it is referred to as'myocardial ischemic event.

Anonymous Patient Answer

What are common treatments for myocardial ischemia?

There are numerous and varied treatment options for Myocardial Ischemia, with no single method proving most efficacious in all patients. Because Myocardial ischemia has a prevalence that reaches 10 million per year, it is likely that many patients with Myocardial ischemia are untreated or undertreated.

Anonymous Patient Answer

What causes myocardial ischemia?

Patients with acute coronary syndromes often present with evidence of coronary artery disease that has been previously unrecognized or not recognized by chest pain and symptoms. Coronary angiography can detect coronary artery disease without coronary angiography and can exclude other pathologies as the cause of complaints.

Anonymous Patient Answer

Can myocardial ischemia be cured?

Many patients with myocardial ischemia show good long-term results. The high degree of ischemic heart disease is likely to be the cause of their frequent adverse cardiac events. In these patients, aggressive risk factor modification has potential to reduce morbidity and mortality, possibly with resultant improvement in quality of life.

Anonymous Patient Answer

Does post-pci ffr improve quality of life for those with myocardial ischemia?

Post-PCI ffr did reduce angina episodes and improves patient mental health and emotional wellbeing, independent of coronary artery treatment type. The impact of PCI ffr on emotional health and patient perceived health was the subject of some debate during this study. Although the differences in the ffr group were not large, the differences were statistically significant and could be of significant clinical relevance. Findings from a recent study could be explained by a reduction in angina episodes but the underlying mechanism is not known.

Anonymous Patient Answer

Does myocardial ischemia run in families?

Familial history is a strong predictor of ischemia. Because a family history of ischemia was found to be significant even when all other risk factors were fully controlled for family history of IHD is a strong indicator that some of the risk may be hereditable.

Anonymous Patient Answer

What is post-pci ffr?

(1) post-PCI ffr and in-hospital mortality are associated with worse clinical outcomes after CABG; (2) the association with mortality persists for 1 year after discharge, and it is related to the severity of coronary arteries disease and impaired left ventricular function; (3) post-PCI ffl may help define, during follow-up, those patients at risk of worse outcomes.

Anonymous Patient Answer

Is post-pci ffr typically used in combination with any other treatments?

This analysis suggests the importance of using a complete revascularization protocol after a ST-elevation MI. Post-PCI ffr seems to be effective in combination with standard treatment in the acute setting. The benefit in the chronic setting is less clear.

Anonymous Patient Answer

What is the latest research for myocardial ischemia?

There are many different ways that clinicians and patients alike can manage and help treat myocardial ischemia. Physicians should take the opportunity to use these resources to the full with people who suffer with ischemic heart disease. This review will help physicians begin to recognize the resources they may already have available as well as the resources they may begin to look for. This review helps physicians recognize and prioritize which resources to use.

Anonymous Patient Answer

Has post-pci ffr proven to be more effective than a placebo?

On the basis of the current results, no difference was detectable between rTPA and a placebo when used to treat infarcts in patients with complete thrombolysis, i.e., a TIMI 3 grade on initial imaging.

Anonymous Patient Answer
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