Biochemical and Electrocardiographic Signatures in the Detection of Exercise-induced Myocardial Ischemia

NCT01838148 | Recruiting

• 1 other identifier: BASEL VIII
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim is to perform the largest study worldwide to evaluate novel biochemical and electrocardiographic signatures alone as well as in combination with the standard 12-lead exercise ECG in the detection of exercise-induced myocardial ischemia (diagnostic endpoint). The secondary aim is to evaluate these innovative tools in the risk prediction for the occurrence of cardiovascular death and acute myocardial infarction during long-term follow-up.

Conditions

Coronary Artery Disease; Angina, Stable; Exercise Test; Biological Markers; SPECT

Keywords

coronary artery disease; angina, stable; exercise test; biological Markers; SPECT

Outcome Measures

Primary Outcomes (1)

• Diagnostic utility of novel biochemical and electrocardiographic signatures

  Diagnostic utility of biochemical (i.e. cardiac troponin, brain natriuretic peptide) and electrocardiographic signatures alone as well as in combination with the standard 12-lead exercise ECG in the detection of exercise-induced myocardial ischemia, mainly quantified by the area under the receiver operating characteristics curves (AUC ROC) and positive/negative predictive values, respectively.

  baseline

Secondary Outcomes (4)

• One year event-free survival

  360 days

• Two year event-free survival

  2 years

• Five year event-free survival

  5 years

• Eight year event-free survival

  8 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients presenting with suspected exercise-induced myocardial ischemia referred for rest/ergometry myocardial perfusion SPECT.

You may qualify if:

• Patients presenting with suspected exercise-induced myocardial ischemia referred for rest/ergometry myocardial perfusion SPECT

You may not qualify if:

• Age \< 18 years
• Pregnancy
• Unable or unwilling to give informed consent
• Symptoms at rest or minor exertion

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Related Publications (6)

• Amrein M, Li XS, Walter J, Wang Z, Zimmermann T, Strebel I, Honegger U, Leu K, Schafer I, Twerenbold R, Puelacher C, Glarner N, Nestelberger T, Koechlin L, Ceresa B, Haaf P, Bakula A, Zellweger M, Hazen SL, Mueller C. Gut microbiota-dependent metabolite trimethylamine N-oxide (TMAO) and cardiovascular risk in patients with suspected functionally relevant coronary artery disease (fCAD). Clin Res Cardiol. 2022 Jun;111(6):692-704. doi: 10.1007/s00392-022-01992-6. Epub 2022 Feb 26.

  PMID: 35220448 DERIVED

• Walter JE, Amrein MLF, Schafer I, Zimmermann T, Lopez-Ayala P, Boeddinghaus J, Twerenbold R, Puelacher C, Nestelberger T, Wussler D, Honegger U, Badertscher P, Eugen-Olsen J, Koechlin L, Fahrni G, Jeger R, Kaiser C, Zellweger M, Mueller C. Soluble urokinase plasminogen activator receptor and functionally relevant coronary artery disease: a prospective cohort study. Biomarkers. 2022 May;27(3):278-285. doi: 10.1080/1354750X.2022.2038269. Epub 2022 Feb 15.

  PMID: 35112976 DERIVED

• Walter J, du Fay de Lavallaz J, Koechlin L, Zimmermann T, Boeddinghaus J, Honegger U, Strebel I, Twerenbold R, Amrein M, Nestelberger T, Wussler D, Puelacher C, Badertscher P, Zellweger M, Fahrni G, Jeger R, Kaiser C, Reichlin T, Mueller C. Using High-Sensitivity Cardiac Troponin for the Exclusion of Inducible Myocardial Ischemia in Symptomatic Patients: A Cohort Study. Ann Intern Med. 2020 Feb 4;172(3):175-185. doi: 10.7326/M19-0080. Epub 2020 Jan 7.

  PMID: 31905377 DERIVED

• Badertscher P, Strebel I, Honegger U, Schaerli N, Mueller D, Puelacher C, Wagener M, Abacherli R, Walter J, Sabti Z, Sazgary L, Marbot S, du Fay de Lavallaz J, Twerenbold R, Boeddinghaus J, Nestelberger T, Kozhuharov N, Breidthardt T, Shrestha S, Flores D, Schumacher C, Wild D, Osswald S, Zellweger MJ, Mueller C, Reichlin T. Automatically computed ECG algorithm for the quantification of myocardial scar and the prediction of mortality. Clin Res Cardiol. 2018 Sep;107(9):824-835. doi: 10.1007/s00392-018-1253-z. Epub 2018 Apr 17.

  PMID: 29667014 DERIVED

• Puelacher C, Wagener M, Honegger U, Assadian M, Schaerli N, Mueller D, Strebel I, Twerenbold R, Boeddinghaus J, Nestelberger T, Wildi K, Sabti Z, Sazgary L, Badertscher P, du Fay de Lavallaz J, Marbot S, Kaiser C, Wild D, Zellweger MJ, Reichlin T, Mueller C. Combining high-sensitivity cardiac troponin and B-type natriuretic peptide in the detection of inducible myocardial ischemia. Clin Biochem. 2018 Feb;52:33-40. doi: 10.1016/j.clinbiochem.2017.10.014. Epub 2017 Nov 8.

  PMID: 29107010 DERIVED

• Sou SM, Puelacher C, Twerenbold R, Wagener M, Honegger U, Reichlin T, Schaerli N, Pretre G, Abacherli R, Jaeger C, Rubini Gimenez M, Wild D, Rentsch KM, Zellweger MJ, Mueller C. Direct comparison of cardiac troponin I and cardiac troponin T in the detection of exercise-induced myocardial ischemia. Clin Biochem. 2016 Apr;49(6):421-432. doi: 10.1016/j.clinbiochem.2015.12.005. Epub 2015 Dec 17.

  PMID: 26708172 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA, plasma

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Mueller, Prof. Dr. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Mueller, Prof. Dr. MD

CONTACT

+ 41 61328 65 49; Christian.Mueller@usb.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 23, 2013
• Study Start: May 1, 2004
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CH (1)