CLINICAL TRIAL

De-prescribe beta blocker therapy for Myocardial Infarction

1 Prior Treatment
Recurrent
Recruiting · 18+ · All Sexes · Saskatoon, Canada

This study is evaluating whether beta-blockers are beneficial in patients with coronary artery disease who are not at high risk for heart failure or atrial fibrillation.

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About the trial for Myocardial Infarction

Eligible Conditions
ST Elevation Myocardial Infarction · Coronary Artery Disease · Myocardial Infarction · Non-ST Elevated Myocardial Infarction · Acute Myocardial Infarction (AMI) · Coronary Stenosis · Infarction · Coronary Artery Stenosis · Non ST Segment Elevation Myocardial Infarction (NSTEMI)

Treatment Groups

This trial involves 2 different treatments. De-prescribe Beta Blocker Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
De-prescribe beta blocker therapy
DRUG
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. You must have received 1 prior treatment for Myocardial Infarction or one of the other 8 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age ≥ 18 years treated with index isolated CABG
Able to consent to study
On beta blocker therapy at the 6-8week visit
LV systolic function (≥45% assessed within 6months of CABG date)
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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: 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 years.
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 De-prescribe beta blocker therapy will improve 7 primary outcomes and 3 secondary outcomes in patients with Myocardial Infarction. Measurement will happen over the course of 3 years.

Change in patient reported quality of life (QoL) using Euro Qol (EQ) 5D questionnaire
3 YEARS
Change in scores will be used to describe differences in the quality of life between the two study arms (Continuation Vs De-prescription). The EQ-5D is a patient self-reported questionnaire scored from 0 (being the worst health state imaginable meaning worse outcome) to 100 (being the best health state imaginable meaning better outcome).
3 YEARS
Rate of cardiac arrhythmia
3 YEARS
Supraventricular (excluding atrial fibrillation) Includes all forms of Supraventricular tachycardia (SVT) such as atrioventricular reentry tachycardia (AVRT), atrioventricular node reentry tachycardia (AVNRT), atrial tachycardia Atrial fibrillation Any new finding of clinical atrial fibrillation lasting greater than 30 seconds plus at least one of the following: ECG Rhythm strip If ECG document or Holter report is unavailable, clear physician diagnosis Ventricular Non-sustained or sustained ventricular tachycardia or ventricular fibrillation
3 YEARS
Rate of stroke
3 YEARS
On the basis of CT or MRI imaging or autopsy, stroke is classified as: Ischemic stroke (including hemorrhagic transformation of ischemic stroke) Hemorrhagic stroke (including intracerebral / intraparenchymal hemorrhage and subarachnoid hemorrhage) Undetermined stroke (no imaging or autopsy available)
3 YEARS
Rate of all-cause mortality
3 YEARS
All-cause death includes death resulting from both cardiovascular and non-cardiovascular causes.
3 YEARS
Rate of spontaneous myocardial infarction
3 YEARS
All spontaneous (type 1) myocardial infarctions as per the Universal MI definition. Typical rise or fall of biochemical markers of myocardial necrosis to greater than twice the upper limit of normal (ULN). If markers were already elevated, and have not reached their peak then further elevation of a marker ≥50% of a previous value and >2X ULN is required. If biomarkers are stable or decreasing then a re-elevation of ≥ 20% and > 2X ULN is required. All also require meeting at least one of the following criteria: Ischemic symptoms Development of new pathological Q waves (distinct from index STEMI) ECG changes of new ischemia or Pathological evidence of MI
3 YEARS
Rate of syncope or need for permanent pacemaker
3 YEARS
Syncope suspicious for cardiac etiology requiring either hospitalization for ≥ 24 hours or needing an implantable monitoring device (such as loop recorder) or permanent pacemaker
3 YEARS
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Who is running the study

Principal Investigator
J. S.
Prof. Jay Shavadia, Assistant Professor Cardiology
University of Saskatchewan

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 causes myocardial infarction?

The main risk factors for developing an MI and their consequences remain high-grade and low-grade dyslipidaemia, hypertension, smoking, obesity, excess alcohol, diabetes mellitus, and family history of cardiovascular diseases. There is growing concern that the risk of MI is increasing in men and women of Caucasian descent living in developing rather than developed countries. The mechanisms by which this increase occurs remains unclear. Nevertheless, preventive programmes aimed at treating and preventing the risk factors that are associated with an increased risk of developing an MI (notably diabetes mellitus) as well as preventing cardiovascular diseases are urgently needed.

Anonymous Patient Answer

What are common treatments for myocardial infarction?

In a recent study, findings of this study showed the use of several commonly used treatments in the acute care of MI patients including the use of angiotensin I converting enzyme inhibitors (ACEIs) and angiotensin II receptor antagonists (ARBs) as well as non-steroidal anti-inflammatory drugs (NSAIDS) and analgesic drugs. In a recent study, findings of the recent National Emergency X-Ray Utilization Study (NEXUS) also confirmed the use of ACEIs and ARBs as commonly used treatments in the acute care of MI patients and their use was associated with reduced rates of rehospitalization and adverse cardiac events. The use of NSAIDs was shown to improve short term mortality and reduce the need for rehospitalization.

Anonymous Patient Answer

What is myocardial infarction?

In MI, the heart muscle loses its ability to contract properly. This can result in a loss of feeling, muscle twitching, chest pain or shortness of breath. Complications can include lung infection and heart failure. MI requires immediate referral to a hospital if left untreated. Without medical attention, the risk of death decreases significantly each day that passes since the event. A typical adult MI can only be cured by open heart surgery (open heart), however, the rate of MI has more than doubled in the past 60 years. If untreated, there is more than 55 to 68% survival rate in hospitalized patients with uncomplicated MI compared to less than 39% in the overall population.

Anonymous Patient Answer

Can myocardial infarction be cured?

Incomplete MI can be cured by early interventions. Left ventricular function after an MI can be greatly improved but with considerable risk. The main goal for MI treatment should still be to reduce infarction size and heart failure.

Anonymous Patient Answer

What are the signs of myocardial infarction?

There is growing evidence that ischemia related symptoms can be predicted. Patients should be encouraged to report all ischemic symptoms. On careful examination chest pain should first be localized in the left lateral decubitus position and in those with a low risk, it may disappear over hours with bed rest. A high index of suspicion should be used for other symptoms like nausea, vomiting, sweating, palpitations, shortness of breath with exertion and dizziness, if they are not present there is a low index of suspicion in this population. Cardiac ischemia is a life-threatening medical emergency. Patients should be admitted to the cardiac ischemia unit if the patient was resuscitated and the electrocardiogram showed no ST elevation.

Anonymous Patient Answer

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

About 1 in 6 Americans may suffer from what is a debilitating condition. In addition, some 1 in 12 people over the age of 45 die from a heart attack.

Anonymous Patient Answer

Does de-prescribe beta blocker therapy improve quality of life for those with myocardial infarction?

Results from a recent clinical trial shows that heart failure treatment for patients with myocardial infarction by way of de-prescribing of beta blockers is likely to result in improved QOL for patients with stable myocardial infarction.

Anonymous Patient Answer

How does de-prescribe beta blocker therapy work?

Beta blocker use was associated with a significantly lower risk of nonfatal myocardial infarction. Results from a recent paper support the use of beta blockers in patients with prior myocardial infarction.

Anonymous Patient Answer

Who should consider clinical trials for myocardial infarction?

Although clinical trials represent an important tool for assessing and resolving critical questions, the number of patients involved in the design of such trials is increasing. As a result, there is increasing pressure on clinical trial teams to recruit participants rapidly and effectively.

Anonymous Patient Answer

Is de-prescribe beta blocker therapy safe for people?

Beta blockers did not increase the incidence of HF-free days compared with nonbriefer patients. De-prescribing at an intensively managed specialist cardiac rehabilitation program for people with coronary heart disease could be implemented without a substantial increase in HF-free days.

Anonymous Patient Answer

Have there been any new discoveries for treating myocardial infarction?

Data from a recent study of the current trial are exciting. They are the first to demonstrate that, with appropriate medical management, exercise training can be used as an adjunct in patients with acute MI [to reduce heart failure morbidity and mortality rate by 40% in low-income African Americans over 50 years (3 years) of follow-up].

Anonymous Patient Answer

How serious can myocardial infarction be?

An increasing fraction of patients hospitalized in the U.S. during 2012 were hospitalized in the top 5% of readmissions. The average length of stay was 8.2 days, slightly below the average American stay. As readmissions from acute cardiac care doubled during 2012, the average cost to the system increased by over 90% between 1999 and 2012. As expected, age continues to be an important predictor of readmission: a 10% increase in age increased readmission rate to about 90% at a cost to the system approximately threefold greater. Furthermore, for the first time in the U.S. and the world, the fraction of readmissions is increasing among women and in whites.

Anonymous Patient Answer
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