Management for Heart Attack After Surgery

Overseen By Melodie Boko, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Antiplatelets, Statins, ACEI/ARBs

Disqualifiers: Cirrhosis, Peptic ulcer, Thrombocytopenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to assist individuals with heart injuries following non-heart-related surgery. Researchers aim to determine if referring patients to a heart specialist for additional care (the intervention group) improves recovery compared to standard treatment. The goal is to assess whether this extra care reduces the risk of serious heart problems. Individuals who have undergone non-heart surgery and then experienced a heart issue, such as a heart attack, may qualify for this trial if they are not already taking two common heart medications. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance recovery strategies for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are already on two of the three secondary cardiovascular prevention medications (antiplatelet, statin, or ACEI/ARB), you cannot participate in the trial.

What prior data suggests that this protocol is safe for managing myocardial injury after noncardiac surgery?

Research has shown that treatments used to prevent heart problems in individuals who have had heart attacks outside of surgery might also benefit those with heart damage after non-heart-related surgery (MINS). These treatments are generally well-tolerated by patients. Studies indicate that people with MINS often have conditions like high blood pressure and coronary artery disease, common among heart patients. This suggests that these preventive treatments are likely safe, as they are already widely used in similar situations. Although this trial is still in the early stages of determining the best way to manage MINS, the treatments under consideration have a history of safety in related cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the approach of systematic referral for secondary cardiovascular prevention because it offers a proactive strategy for managing heart attack risks after noncardiac surgery. Unlike the standard of care, which typically involves following general post-surgery protocols, this method involves systematically referring patients to an internist within six weeks to tailor prevention strategies based on individual risk factors. This personalized and timely intervention could potentially improve outcomes by addressing specific cardiovascular risks more effectively than generic care approaches.

What evidence suggests that this trial's treatments could be effective for managing myocardial injury after noncardiac surgery?

Research has shown that preventing heart problems can benefit those who have had heart attacks outside of surgery. This trial compares two approaches for managing heart damage after non-heart-related surgery, known as MINS. One group receives standard care, while another receives systematic referral for secondary cardiovascular prevention. People with MINS often have conditions like high blood pressure, heart disease, and kidney problems, which increase the risk of heart issues. Managing these risk factors may reduce the chance of further heart problems. Early findings suggest this approach could help reduce complications after surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Emmanuelle Duceppe, MD PhD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for patients who have experienced myocardial injury after noncardiac surgery, which can lead to heart attacks and delayed wound healing. The study aims to include those who could benefit from secondary cardiovascular prevention typically used outside of a surgical context.

Inclusion Criteria

I have had surgery that was not on my heart.

Provide written informed consent to participate in the SYNERGY pilot trial

I had a heart injury after surgery not related to the heart, without a clear non-heart related cause.

Exclusion Criteria

Previously enrolled in the SYNERGY pilot trial

I am allergic or have a bad reaction to ACEI or ARB medications.

I am currently taking two out of three heart disease prevention medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either a control group receiving usual care or an intervention group that receives referral to a specialist for secondary cardiovascular prevention

6 months

Follow-up

Participants are monitored for clinical cardiovascular outcomes, medication adherence, and lifestyle changes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Intervention Group

Trial Overview

The SYNERGY pilot trial is testing the effectiveness of systematic referral for secondary cardiovascular prevention in improving outcomes for patients with myocardial injury post-noncardiac surgery. It's gathering initial data to plan a larger future study.

How Is the Trial Designed?

Group I: Standard of care Active Control 1 Intervention

Patients who had myocardial injury after noncardiac surgery are assigned to receive usual care.

Group II: Systematic referral for secondary cardiovascular prevention Active Control 1 Intervention

Systematic referral to an internist within 6 weeks after myocardial injury after noncardiac surgery for implementation of secondary cardiovascular prevention strategies, individualized the patient's risk factors.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6776733/

Myocardial Injury after Non-Cardiac Surgery - PubMed Central

Patients with MINS were significantly more likely to have hypertension, coronary artery disease (CAD), prior MI, heart failure, and kidney disease compared with ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06768034

Study Details | NCT06768034 | SecondarY Prevention and ...

Interventions commonly used for cardiovascular prevention in patients who had a heart attack outside of a surgery context could also be beneficial in patient ...

3.

researchgate.net

researchgate.net/publication/332447133_Myocardial_Injury_After_Noncardiac_Surgery_A_Systematic_Review_and_Meta-Analysis

Myocardial Injury After Noncardiac Surgery: A Systematic ...

... Patients who experienced MINS were more likely to have hypertension, coronary artery disease, previous MI, heart failure, and renal disease.

4.

academic.oup.com

academic.oup.com/eurheartj/advance-article-pdf/doi/10.1093/eurheartj/ehz301/46640078/ehz301.pdf

Myocardial injury after non-cardiac surgery

stability (e.g. cardiac ischaemia, heart failure). ... Aspirin in the primary and secondary prevention of vascular disease: collabora-.

5.

ahajournals.org

ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.113.002128

Myocardial Injury After Noncardiac Surgery and its ...

Preexisting troponin I elevations may occur in patients with renal failure or other cardiovascular conditions. The cause of the higher ...