Submaximal Cardiopulmonary Exercise Testing for Detection of Myocardial Injury After Noncardiac Surgery

NCT06474754 | Recruiting DMC FDA Device

• 1 other identifier: 2000037991
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether physicians can associate evidence of myocardial injury after surgery with findings obtained from submaximal cardiopulmonary exercise testing. The main questions are: Is detection of postoperative myocardial injury with submaximal cardiopulmonary exercise testing superior to using usual care? And which submaximal cardiopulmonary exercise testing measure is better? Participants will undergo evaluation with a short submaximal cardiopulmonary exercise test, then undergo surgery. Myocardial injury will be measured on postoperative days 0, 1, 2, and 3 (during and up to 3 days after surgery). These results will analyzed by comparing it to findings from the submaximal cardiopulmonary exercise test. If there is a relationship, this will help anesthesiologists and surgeons assign certain treatments that may reduce the risk of developing myocardial injury after surgery.

Conditions

Myocardial Injury After Non-cardiac Surgery; Submaximal Exercise Performance; Preoperative Period

Keywords

submaximal cardiopulmonary exercise testing; MINS; myocardial injury after noncardiac surgery; perioperative myocardial injury; anesthesiology

Outcome Measures

Primary Outcomes (1)

• MINS

  Myocardial Injury after noncardiac surgery. Measurement: High-Sensitivity Troponin assay with an abnormal value defined as 14 nanograms per liter or greater.

  Operative Day 0, Postoperative Day 1, 2 or 3

Secondary Outcomes (3)

• 30-day Major Adverse Cardiovascular Events

  Postoperative Day 1 through Postoperative Day 30

• Length of Stay

  From operative day 0 through hospital discharge up to postoperative day 180

• Readmission

  Postoperative Day One through Postoperative Day 60.

Study Arms (1)

Submaximal cardiopulmonary exercise testing

EXPERIMENTAL

Single arm design; selected participants will receive both usual care (Duke Activity Status Index) and submaximal cardiopulmonary exercise testing. All participants will receive high-sensitivity troponin measurements on operative day 1 and postoperative day 1,2,3

Diagnostic Test: High-sensitivity troponin, serum; Diagnostic Test: Submaximal Cardiopulmonary Exercise Testing; Diagnostic Test: Duke Activity Status Index

Interventions

High-sensitivity troponin, serum DIAGNOSTIC_TEST

A serum derived measure of myocardial injury. Threshold value of 14ng/L.

Also known as: HST

Submaximal cardiopulmonary exercise testing

Submaximal Cardiopulmonary Exercise Testing DIAGNOSTIC_TEST

FDA-approved device uses breath by breath sampling during calibration and exercise challenge. Analysis is performed using a differential pressure pneumotach method for volume calibration and measurement, an infrared sensor for CO2 and a paramagnetic sensor for O2 measurements. Automated calibration using a calibration gas mixture (15.6% O2/5% CO2) is performed at regular intervals. The Shape II calculations used to differentiate causes of exertional dyspnea are Artificial Intelligence (AI) based algorithms and measurements have been previously validated to conventional cardiopulmonary exercise testing methods. Brief smCPET is comprised of a 2-minute calibration phase, 3 minutes of graded exercise using a stair-step and a 1 minute recovery phase for a total of 6 minutes. An instant report is then generated.

Also known as: smCPET

Submaximal cardiopulmonary exercise testing

Duke Activity Status Index DIAGNOSTIC_TEST

A validated measure of preoperative functional capacity which will be utilized to cross-validate smCPET peak VO2. Low DASI score has been found to estimate peak oxygen uptake (VO2), predict MINS, myocardial infarction, and inducible myocardial ischemia on myocardial perfusion scintigraphy.

Also known as: DASI

Submaximal cardiopulmonary exercise testing

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Biological male or female, aged 45 years or older.
• In good general health as evidenced by medical history or diagnosed with metabolic equivalents (self-reported ability to climb 1 flight of stairs).
• Revised Cardiac Risk Index less than or equal to three.
• Willing to accept phlebotomy on operative day 0, 1, 2, and 3, as part of usual care.
• Scheduled for moderate to high-risk elective non-cardiac surgery with an expected 24-72 hour stay within 60 days of enrollment in the study.

You may not qualify if:

• Inability to perform study procedures as defined by inability to achieve greater than 4 metabolic equivalents (cannot climb 1 flight of stairs reliably).
• Pregnancy or lactation.
• Inability to give independent informed consent.
• Revised cardiac risk index greater than 3.
• Recent myocardial infarction (less than 6 weeks).
• Recent anginal symptoms (stable or unstable) within past 6 months.
• Recent admission or endorsement for congestive heart failure within 6 months
• Recent admission or endorsement for syncope within 6 months.
• Symptomatic tachy- or bradyarrhythmia (supraventricular tachcardia, ventricular tachycardia with symptoms of intermittent dizziness, pre- syncopal events)
• Uncorrected severe valvular heart disease (severe aortic, tricuspid or mitral stenosis)
• Acute pulmonary embolism or deep vein thrombosis (within past 6 months)
• Uncontrolled pulmonary edema
• Uncontrolled symptomatic cardiac arrhythmias.
• Active endocarditis
• Active myocarditis or pericarditis

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University; Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Related Publications (4)

• Snowden CP, Prentis JM, Anderson HL, Roberts DR, Randles D, Renton M, Manas DM. Submaximal cardiopulmonary exercise testing predicts complications and hospital length of stay in patients undergoing major elective surgery. Ann Surg. 2010 Mar;251(3):535-41. doi: 10.1097/SLA.0b013e3181cf811d.

  PMID: 20134313 BACKGROUND

• Le Manach Y, Perel A, Coriat P, Godet G, Bertrand M, Riou B. Early and delayed myocardial infarction after abdominal aortic surgery. Anesthesiology. 2005 May;102(5):885-91. doi: 10.1097/00000542-200505000-00004.

  PMID: 15851872 BACKGROUND

• Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005 Sep 13;173(6):627-34. doi: 10.1503/cmaj.050011.

  PMID: 16157727 BACKGROUND

• Patel AY, Eagle KA, Vaishnava P. Cardiac risk of noncardiac surgery. J Am Coll Cardiol. 2015 Nov 10;66(19):2140-2148. doi: 10.1016/j.jacc.2015.09.026.

  PMID: 26541926 BACKGROUND

Study Officials

• Zyad J Carr, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zyad J Carr, M.D.

CONTACT

203-785-3689; zyad.carr@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blinded Phase IV diagnostic clinical trial study design

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 26, 2024
• Study Start: March 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: For 24 months after initial study publication.
• Access Criteria: CITI trained certified individuals that meet criteria set forth by physionet.org.

Locations

US (1)