Study for Evaluation of Newly Onset Chest Pain and Rapid Diagnosis of Myocardial Necrosis (stenoCARDIA)

Study for Evaluation of Newly Onset Chest Pain and Rapid Diagnosis of Myocardial Necrosis (stenoCARDIA)

This is a national multi-center, prospective surveillance study in patients with suspected acute coronary syndrome. Eligible patients must present to one of the participating Emergency Departments within 24 hours from the time of symptom onset. Approximately 2000 patients >18 and <85 years of age are planned to be enrolled.

Upon enrollment in the Emergency Department, a venous blood sample will be obtained from each patient for analysis. The patient's diagnostic work-up, treatment and disposition will continue per the standards of the treating institution. Results will be recorded for ECGs, any cardiac biomarkers measured at the site and any follow-up cardiac objective tests performed for evidence of coronary artery disease and/or myocardial damage (exercise treadmill, coronary angiography, cardiac thallium or technetium scintigraphy, etc).

The Principal Investigator at each site will evaluate the results of the diagnostic cardiac tests performed for that patient to determine whether each patient enrolled at their site has a final diagnosis of ACS.

The status of each patient will also be assessed at 1 month and 6 months after enrollment for intercurrent Major Adverse Cardiac Events (MACE), including myocardial infarction, cardiac revascularization and death.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction

• Study Type: Observational
• Enrollment (Actual): 1818

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will focus on patients presenting to the ED within 24 hours of the onset of chest pain. Both patients then discharged to home as well as patients subsequently admitted to the hospital are eligible for the study and may be enrolled.

Description

Inclusion Criteria:

• Only patients who are able to give consent. This has to be carefully verified in each case, by the doctors leading the study
• Men or women >18 and <85 years of age
• Patients with chest discomfort within last 24h and suspected Acute Coronary Syndrome (STEMI, NSTEMI and unstable angina)
• Patient experiencing at least 30 minutes of chest discomfort or other symptoms consistent with possible ACS; (Note: Patients who have symptoms of shorter duration that resolved due to pharmacologic intervention may be included.)
• Written informed consent

Exclusion Criteria:

• Age <18 or >85 years
• Inpatient in the hospital prior to onset of symptoms.
• Obvious traumatic disease
• Prisoners or other institutionalized or vulnerable individuals
• Major surgery within last 4 weeks
• Patients with cardiogenic shock
• Other significant laboratory abnormalities that the investigator feels may compromise the patient's safety by participation in the study
• Women who are pregnant or breast feeding
• Obvious iv drug abuse
• Refusal to provide written informed consent
• Unavailability of a telephone number and insufficient contact information as well as permanent residence abroad
• Unreliability as a study participant as based on the investigator's prior knowledge of the patient, such as the inability or willingness to participate in or complete the study or the presence of concurrent physical or psychological disorders that may make it impractical for the patient to participate in or complete the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of acute coronary syndromes	The primary end-point of the study is the early diagnosis of acute coronary syndromes using a combined analysis of multiple markers compared to single marker analyses (final diagnosis of ACS as reason for hospital admission).	30 days

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Stefan Blankenberg, MD, University Heart Center Hamburg

Publications and helpful links

General Publications

• Keller T, Zeller T, Ojeda F, Tzikas S, Lillpopp L, Sinning C, Wild P, Genth-Zotz S, Warnholtz A, Giannitsis E, Mockel M, Bickel C, Peetz D, Lackner K, Baldus S, Munzel T, Blankenberg S. Serial changes in highly sensitive troponin I assay and early diagnosis of myocardial infarction. JAMA. 2011 Dec 28;306(24):2684-93. doi: 10.1001/jama.2011.1896.
• Keller T, Zeller T, Peetz D, Tzikas S, Roth A, Czyz E, Bickel C, Baldus S, Warnholtz A, Frohlich M, Sinning CR, Eleftheriadis MS, Wild PS, Schnabel RB, Lubos E, Jachmann N, Genth-Zotz S, Post F, Nicaud V, Tiret L, Lackner KJ, Munzel TF, Blankenberg S. Sensitive troponin I assay in early diagnosis of acute myocardial infarction. N Engl J Med. 2009 Aug 27;361(9):868-77. doi: 10.1056/NEJMoa0903515.
• Haller PM, Neumann JT, Sorensen NA, Hartikainen TS, Gossling A, Lehmacher J, Keller T, Zeller T, Blankenberg S, Westermann D. The association of anaemia and high-sensitivity cardiac troponin and its effect on diagnosing myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1187-1196. doi: 10.1093/ehjacc/zuab066.
• Haller PM, Boeddinghaus J, Neumann JT, Sorensen NA, Hartikainen TS, Gossling A, Nestelberger T, Twerenbold R, Lehmacher J, Keller T, Zeller T, Blankenberg S, Mueller C, Westermann D. Performance of the ESC 0/1-h and 0/3-h Algorithm for the Rapid Identification of Myocardial Infarction Without ST-Elevation in Patients With Diabetes. Diabetes Care. 2020 Feb;43(2):460-467. doi: 10.2337/dc19-1327. Epub 2019 Dec 16. Erratum In: Diabetes Care. 2022 Jul 7;45(7):1701-1702.
• Neumann JT, Twerenbold R, Ojeda F, Sorensen NA, Chapman AR, Shah ASV, Anand A, Boeddinghaus J, Nestelberger T, Badertscher P, Mokhtari A, Pickering JW, Troughton RW, Greenslade J, Parsonage W, Mueller-Hennessen M, Gori T, Jernberg T, Morris N, Liebetrau C, Hamm C, Katus HA, Munzel T, Landmesser U, Salomaa V, Iacoviello L, Ferrario MM, Giampaoli S, Kee F, Thorand B, Peters A, Borchini R, Jorgensen T, Soderberg S, Sans S, Tunstall-Pedoe H, Kuulasmaa K, Renne T, Lackner KJ, Worster A, Body R, Ekelund U, Kavsak PA, Keller T, Lindahl B, Wild P, Giannitsis E, Than M, Cullen LA, Mills NL, Mueller C, Zeller T, Westermann D, Blankenberg S; COMPASS-MI Study Group. Application of High-Sensitivity Troponin in Suspected Myocardial Infarction. N Engl J Med. 2019 Jun 27;380(26):2529-2540. doi: 10.1056/NEJMoa1803377. Erratum In: N Engl J Med. 2022 Nov 3;387(18):1724.
• Sorensen NA, Neumann JT, Ojeda F, Schafer S, Magnussen C, Keller T, Lackner KJ, Zeller T, Karakas M, Munzel T, Blankenberg S, Westermann D, Schnabel RB. Relations of Sex to Diagnosis and Outcomes in Acute Coronary Syndrome. J Am Heart Assoc. 2018 Mar 10;7(6):e007297. doi: 10.1161/JAHA.117.007297.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): December 31, 2008
• Study Completion (Actual): December 31, 2008

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Emergency department; Troponin
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Myocardial Infarction; Infarction; Chest Pain; Necrosis
• Other Study ID Numbers: 837.075.06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No