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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for managing heart attacks after surgery?

The research on enhanced recovery after cardiac surgery shows that following specific guidelines can help patients recover faster and improve outcomes after heart surgery. This suggests that structured recovery programs may be effective in managing heart attacks after surgery. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Beta-blockers, used to reduce heart risks during surgery, have been shown to help prevent heart-related issues in patients with coronary artery disease (heart disease). This suggests they are generally safe for managing heart risks in surgical settings. ^{6 7 8 9 10}

How does the treatment for heart attack after surgery differ from other treatments?

The treatment for heart attack after surgery, known as rescue percutaneous coronary intervention (PCI), is unique because it is performed immediately after coronary artery bypass grafting (CABG) to address graft failure and prevent severe complications like cardiogenic shock. This approach offers a viable alternative to immediate reoperation, potentially improving patient outcomes by quickly restoring blood flow to the heart. ^{11 12 13 14 15}

What is the purpose of this trial?

Cardiac complications, particularly myocardial injury after noncardiac surgery (MINS), significantly contribute to 30-day mortality, affecting about 1 in 10 patients after noncardiac surgery. Despite its prevalence and serious implications, there is no consensus on managing myocardial injury after noncardiac surgery in clinical practice. Interventions commonly used for cardiovascular prevention in patients who had a heart attack outside of a surgery context could also be beneficial in patient with MINS. This pilot study trial aims to gather feasibility data, such as recruitment rates and intervention adherence that will guide on the design and inform on sample size of a future study with large pragmatic randomized controlled trial on the impact of systematic referral for secondary cardiovascular prevention on outcomes in patients who had a MINS.

Research Team

Emmanuelle Duceppe, MD PhD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Association between improved compliance with enhanced recovery after cardiac surgery guidelines and postoperative outcomes: A retrospective study. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Rapid clinical evaluation: an early warning cardiac surgical scoring system for hand-held digital devices. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Enhancing postoperative recovery of cardiac surgery patients: a randomized clinical trial of an advanced practice nursing intervention. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Rapid recovery management: the effects on the patient who has undergone heart surgery. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Audit of co-management and critical care outreach for high risk postoperative patients (The POST audit). [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Multivariable predictors of postoperative cardiac adverse events after general and vascular surgery: results from the patient safety in surgery study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events in coronary artery bypass graft (CABG) trials: a systematic review and analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Using beta-blockers to cut perioperative risk in CAD. Cardioprotective strategies for noncardiac surgery. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A morbidity and mortality conference-based classification system for adverse events: surgical outcome analysis: part I. [2019]

10. England pubmed.ncbi.nlm.nih.gov

The effect of critical care outreach on postoperative serious adverse events. [2006]

11. Italy pubmed.ncbi.nlm.nih.gov

Which technique is suitable for management of acute myocardial infarction following coronary artery bypass surgery, rescue percutaneous coronary intervention or open heart surgery? A case-series studies. [2016]

12. Germany pubmed.ncbi.nlm.nih.gov

[General surgical interventions in heart surgery patients]. [2006]

13. United States pubmed.ncbi.nlm.nih.gov

Rescue percutaneous coronary intervention immediately following coronary artery bypass grafting. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Coronary artery bypass grafting within thirty days of acute myocardial infarction. Early and late results in 406 patients. [2004]

15. United States pubmed.ncbi.nlm.nih.gov

Emergency coronary bypass surgery: indications and results. [2004]