AzTrials
AzTrials

Cardiovascular DiseasesNCT04789564

Predictive Value of Cardiovascular Magnetic Resonance Related Parameters in STEMI Patients After Primary PCI for Adverse Left Ventricular Remodeling and Major Adverse Cardiovascular Events

An observational study of Cardiovascular Diseases, run by Qian geng 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

This study aim to investigate the predictive value of CMR parameters: infarct size (IS), intramyocardial hemorrhage, microvascular obstruction, area at risk and CMR derived strain parameters with the Major Adverse Cardiovascular Events (MACEs) and myocardial remodeling afterinfarction. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
cardiovascular magnetic resonance (CMR)
How many people
500 participants
Where
1 siteChina
Study dates
1 Jan 2014to 31 Dec 2021
How long will I take part?
5 Years
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: Investigators will enroll 500 patients with STEMI after PCI who were admitted to the Chinese PLA General Hospital and other eight hospitals across China between January 2016 and January 2019. CMR was performed at 7 days and 6 months after primary PCI to assess the final infarction size, microvascular obstruction (MVO), area at risk (AAR) and related strain parameters. All patients will be followed up by 5 years after addimission index.

Who may be able to join

  • Age 18-80 years.
  • clinically diagnosed ST-segment elevation myocardial infarction.
  • Intended to undergo emergency PCI.
  • Voluntary enrollment and signed informed consent form.

Who cannot join

  • undergoing revascularization (PCI or coronary artery bypass grafting (CABG)) within 6 months;
  • Pregnant and breastfeeding women;
  • Contraindications of CMR: implanted cardiac defibrillator (ICD), claustrophobia, allergy to gadolinium
  • Liver or kidney failure;
  • Malignant tumor;
  • Unconscious at present;
Show all 9Show fewer
  • systolic blood pressure (SBP) less than 80 mmHg;
  • Patients with bundle branch or fascicular block, insufficient ECG data.
  • Patients with other significant abnormal signs, laboratory tests and clinical disease are unsuitable for participation in the study accessed by clinicians.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: Predictors of Cardiovascular Magnetic Resonancerelated Parameters: Intramyocardial Hemorrhage, Microvascular Obstruction , Area at Risk and Strain Related Parameters, and Their Effects on Adverse Ventricular Remodeling and MACEs in STEMI Patients After Primary PCI

This study aim to investigate the predictive value of CMR parameters: infarct size (IS), intramyocardial hemorrhage, microvascular obstruction, area at risk and CMR derived strain parameters with the Major Adverse Cardiovascular Events (MACEs) and myocardial remodeling afterinfarction.

Read the detailed description

Investigators will enroll 500 patients with STEMI after PCI who were admitted to the Chinese PLA General Hospital and other eight hospitals across China: Wuhan Asia Heart Hospital; the First People's Hospital of Yunlin; Chaoyang Hospital, Capital Medical University; Hainan Hospital of PLA General Hospital; the Second Affiliated Hospital of Nanchang University; the Second Hospital of Hebei Medical University; Guizhou Provincial People's Hospital; Affiliated Hospital of Zunyi Medical College between January 2014 and December 2019. CMR was performed at 7 days and 6 months after primary PCI to assess the final infarction size(IS), microvascular obstruction (MVO), intramyocardial hemorrhage(IMH), area at risk (AAR) and related strain parameters. All patients will be followed up by 5 years after adimission. Cardiovascular events concluded stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction, and all cause death. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.

Being tested
cardiovascular magnetic resonance (CMR)
Keywords
Intramyocardial Hemorrhage(IMH), Microvascular Obstruction(MVO), Area at Risk(AAR), CMR Related Strain, ST-segment elevation myocardial
Medical subject headings
Cardiovascular Diseases

What participants receive

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

  • cardiovascular magnetic resonance (CMR)Diagnostic test

    Testing CMR on patients of 7 days and 6 months after myocardial infarction

What is being measured

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

  1. MACEs

    MACEs concluding All-cause mortality, stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction

    Measured: follow up in five years

Secondary outcomes (2)

  1. Left ventricular remodeling

    Increase of LVEDV >20%

    Measured: 6 month after PCI

  2. Contrast-induced acute kidney injury

    25% or 0.5 mg/dl increase in serum creatinine

    Measured: 48 to 72 hours after PCI

Timeline

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

  1. First posted9 Mar 2021
  2. Study start1 Jan 2014
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2021

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
500 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04789564
Sponsor's protocol ID
qgeng-2021-2-16
Status last verified
Mar 2021
First submitted
5 Mar 2021
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Korosoglou G, Giusca S, Montenbruck M, Patel AR, Lapinskas T, Gotze C, Zieschang V, Al-Tabatabaee S, Pieske B, Florian A, Erley J, Katus HA, Kelle S, Steen H. Fast Strain-Encoded Cardiac Magnetic Resonance for Diagnostic Classification and Risk Stratification of Heart Failure Patients. JACC Cardiovasc Imaging. 2021 Jun;14(6):1177-1188. doi: 10.1016/j.jcmg.2020.10.024. Epub 2021 Jan 13.

    PubMed 33454266

  • Amier RP, Tijssen RYG, Teunissen PFA, Fernandez-Jimenez R, Pizarro G, Garcia-Lunar I, Bastante T, van de Ven PM, Beek AM, Smulders MW, Bekkers SCAM, van Royen N, Ibanez B, Nijveldt R. Predictors of Intramyocardial Hemorrhage After Reperfused ST-Segment Elevation Myocardial Infarction. J Am Heart Assoc. 2017 Aug 15;6(8):e005651. doi: 10.1161/JAHA.117.005651.

    PubMed 28862937

  • Kidambi A, Mather AN, Motwani M, Swoboda P, Uddin A, Greenwood JP, Plein S. The effect of microvascular obstruction and intramyocardial hemorrhage on contractile recovery in reperfused myocardial infarction: insights from cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2013 Jun 27;15(1):58. doi: 10.1186/1532-429X-15-58.

    PubMed 23806080

  • Durante A, Laricchia A, Benedetti G, Esposito A, Margonato A, Rimoldi O, De Cobelli F, Colombo A, Camici PG. Identification of High-Risk Patients After ST-Segment-Elevation Myocardial Infarction: Comparison Between Angiographic and Magnetic Resonance Parameters. Circ Cardiovasc Imaging. 2017 Jun;10(6):e005841. doi: 10.1161/CIRCIMAGING.116.005841.

    PubMed 28592591

  • Liang K, Nakou E, Del Buono MG, Montone RA, D'Amario D, Bucciarelli-Ducci C. The Role of Cardiac Magnetic Resonance in Myocardial Infarction and Non-obstructive Coronary Arteries. Front Cardiovasc Med. 2022 Jan 17;8:821067. doi: 10.3389/fcvm.2021.821067. eCollection 2021.

    PubMed 35111833

  • Jensch PJ, Stiermaier T, Reinstadler SJ, Feistritzer HJ, Desch S, Fuernau G, de Waha-Thiele S, Thiele H, Eitel I. Prognostic relevance of peri-infarct zone measured by cardiovascular magnetic resonance in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2022 Jan 15;347:83-88. doi: 10.1016/j.ijcard.2021.11.017. Epub 2021 Nov 10.

    PubMed 34767896

  • Scarsini R, Shanmuganathan M, De Maria GL, Borlotti A, Kotronias RA, Burrage MK, Terentes-Printzios D, Langrish J, Lucking A, Fahrni G, Cuculi F, Ribichini F, Choudhury RP, Kharbanda R, Ferreira VM, Channon KM, Banning AP; OxAMI Study Investigators. Coronary Microvascular Dysfunction Assessed by Pressure Wire and CMR After STEMI Predicts Long-Term Outcomes. JACC Cardiovasc Imaging. 2021 Oct;14(10):1948-1959. doi: 10.1016/j.jcmg.2021.02.023. Epub 2021 Apr 14.

    PubMed 33865789

  • Hamirani YS, Wong A, Kramer CM, Salerno M. Effect of microvascular obstruction and intramyocardial hemorrhage by CMR on LV remodeling and outcomes after myocardial infarction: a systematic review and meta-analysis. JACC Cardiovasc Imaging. 2014 Sep;7(9):940-52. doi: 10.1016/j.jcmg.2014.06.012.

    PubMed 25212800

  • Ganame J, Messalli G, Dymarkowski S, Rademakers FE, Desmet W, Van de Werf F, Bogaert J. Impact of myocardial haemorrhage on left ventricular function and remodelling in patients with reperfused acute myocardial infarction. Eur Heart J. 2009 Jun;30(12):1440-9. doi: 10.1093/eurheartj/ehp093. Epub 2009 Apr 3.

    PubMed 19346229

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, run by Qian geng 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 4 inclusion and 9 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 11 Apr 2022. 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?

MACEs (time frame: follow up in five years). 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 NCT04789564, which also lists 9 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 11 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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