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ST Elevation Myocardial InfarctionNCT04660474

Different Reperfusion Timing and Ventricular Arrhythmias in STEMI Patients

An observational study of ST Elevation Myocardial Infarction and Arrhythmia Ventricular, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to investigate the association between different reperfusion timing and ventricular arrhythmias (VAs) to provide evidence for clinical decision-making for patients with ST-segment elevation myocardial infarction (STEMI). Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
517 participants
Where
1 siteChina
Study dates
1 Jul 2019to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: A prospective cohort study was designed to investigate the effects of different reperfusion timing on VAs in STEMI patients. During the patients' follow-up, 24h-dynamic electrocardiography, echocardiography were required to record the incidence of primary outcome and other parameters. Information on SO2RT, demographic characteristics, hypertension, diabetes and dyslipidemia history, drug use, smoking, drinking, biochemical indexes and coronary lesions were also collected.

Who may be able to join

  • STEMI patients undergoing coronary angiography and PCI;
  • can complete 3 follow-up visits well.

Who cannot join

  • without PCI;
  • undergoing thrombolytic therapy;
  • mental diseases;
  • renal failure;
  • stroke sequelae;
  • tumor and a history of revascularization.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: Association of Reperfusion Timing With Short- and Medium-term Ventricular Arrhythmias in Patients With ST-segment Elevation Myocardial Infarction: A Prospective Observational Study

The aim of this study was to investigate the association between different reperfusion timing and ventricular arrhythmias (VAs) to provide evidence for clinical decision-making for patients with ST-segment elevation myocardial infarction (STEMI). All the participants included in the study were diagnosed with STEMI according to the 4th universal definition of myocardial infarction, with a follow-up of 1, 6, 12 months, respectively. Symptom onset-to-reperfusion timing (SO2RT) and 24h-dynamic electrocardiogram parameters were recorded to compare different SO2RT and VAs during 3 follow-up visits.

Read the detailed description

It is Class I recommendation that STEMI require emergency revascularization with no delay. However, arrhythmias after acute myocardial infarction (AMI), particularly VAs, also occur in the early post-MI phase, leading to increased mortality. Previous studies have shown benefits of late reperfusion to electrical stability. The aim of this study was to investigate the association between different reperfusion timing and VAs to provide evidence for clinical decision-making for STEMI. In this multicenter, prospective, observational study, STEMI participants from July 2019 to December 2020 confirmed according to the 4th universal definition of myocardial infarction were enrolled, with a follow-up of 1, 6, 12 months, respectively. SO2RT was defined as the time interval between symptom onset and reperfusion timing which referred to the timing when coronary angiography showed Thrombolysis In Myocardial Infarction (TIMI) blood flow level 2~3 immediately after percutaneous coronary intervention (PCI). The primary end point was VAs on 24h-dynamic electrocardiogram. Secondary outcomes included a composite of death from coronary heart disease, fetal of non-fetal ischemic stroke, revascularization, or chest pain requiring readmission.

Keywords
Symptom Onset-to-Reperfusion Timing (SO2RT), ST Elevation Myocardial Infarction, Arrhythmia Ventricular, Percutaneous Coronary Intervention, Early Reperfusion
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04660474
Study groupRoleWhat they receive
Early reperfusion groupAll patients hospitalized and diagnosed as STEMI according to the 4th universal definition of myocardial infarction underwent coronary angiography and PCI treatment. Patients with SO2RT<24 hours were assigned to Early reperfusion group.
Intermediate reperfusion groupAll patients hospitalized and diagnosed as STEMI according to the 4th universal definition of myocardial infarction underwent coronary angiography and PCI treatment. Patients with SO2RT ranging from 24 hours to 7days were assigned to Intermediate reperfusion group.
Late reperfusion groupAll patients hospitalized and diagnosed as STEMI according to the 4th universal definition of myocardial infarction underwent coronary angiography and PCI treatment. Patients with SO2RT>7days were assigned to Late reperfusion group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAs

    The incidence of ventricular arrhythmias on 24h-dynamic electrocardiogram.

    Measured: 12 months

Secondary outcomes (4)

  1. Death from coronary heart disease

    The incidence of death from coronary heart disease during follow-ups.

    Measured: 12 months

  2. Fetal of non-fetal ischemic stroke

    The incidence of fetal of non-fetal ischemic stroke during follow-ups.

    Measured: 12 months

  3. Revascularization

    The incidence of revascularization during follow-ups.

    Measured: 12 months

  4. Chest pain requiring readmission

    The incidence of chest pain requiring readmission during follow-ups.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start1 Jul 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04660474
Sponsor's protocol ID
VERY-STEMI
Status last verified
May 2024
First submitted
3 Dec 2020
Last updated
23 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

    PubMed 28886621

  • Appleton DL, Abbate A, Biondi-Zoccai GG. Late percutaneous coronary intervention for the totally occluded infarct-related artery: a meta-analysis of the effects on cardiac function and remodeling. Catheter Cardiovasc Interv. 2008 May 1;71(6):772-81. doi: 10.1002/ccd.21468.

    PubMed 18415952

  • Hochman JS, Lamas GA, Buller CE, Dzavik V, Reynolds HR, Abramsky SJ, Forman S, Ruzyllo W, Maggioni AP, White H, Sadowski Z, Carvalho AC, Rankin JM, Renkin JP, Steg PG, Mascette AM, Sopko G, Pfisterer ME, Leor J, Fridrich V, Mark DB, Knatterud GL; Occluded Artery Trial Investigators. Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006 Dec 7;355(23):2395-407. doi: 10.1056/NEJMoa066139. Epub 2006 Nov 14.

    PubMed 17105759

  • Malek LA, Silva JC, Bellenger NG, Nicolau JC, Klopotowski M, Spiewak M, Rassi CH, Lewandowski Z, Kruk M, Rochitte CE, Ruzyllo W, Witkowski A. Late percutaneous coronary intervention for an occluded infarct-related artery in patients with preserved infarct zone viability: a pooled analysis of cardiovascular magnetic resonance studies. Cardiol J. 2013;20(5):552-9. doi: 10.5603/CJ.2013.0141.

    PubMed 24297771

  • Sadanandan S, Buller C, Menon V, Dzavik V, Terrin M, Thompson B, Lamas G, Hochman JS. The late open artery hypothesis--a decade later. Am Heart J. 2001 Sep;142(3):411-21. doi: 10.1067/mhj.2001.117774.

    PubMed 11526353

  • Sadanandan S, Hochman JS. Early reperfusion, late reperfusion, and the open artery hypothesis: an overview. Prog Cardiovasc Dis. 2000 May-Jun;42(6):397-404.

    PubMed 10871162

  • Steigen TK, Buller CE, Mancini GB, Jorapur V, Cantor WJ, Rankin JM, Thomas B, Webb JG, Kronsberg SS, Atchison DJ, Lamas GA, Hochman JS, Dzavik V. Myocardial perfusion grade after late infarct artery recanalization is associated with global and regional left ventricular function at one year: analysis from the Total Occlusion Study of Canada-2. Circ Cardiovasc Interv. 2010 Dec;3(6):549-55. doi: 10.1161/CIRCINTERVENTIONS.109.918722. Epub 2010 Nov 9.

    PubMed 21062997

Questions about this trial

What is this clinical trial studying?

An observational study of ST Elevation Myocardial Infarction and Arrhythmia Ventricular, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAs (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04660474, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.

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