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ST-segment Elevation Myocardial Infarction (STEMI)COOPERATIONNCT04912518

Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction

A study testing Dexmedetomidine (DEX) in people with ST-segment Elevation Myocardial Infarction (STEMI) and Percutaneous Coronary Intervention, run by Harbin Medical University at 9 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a double-blind, multicenter, randomized, placebo-controlled clinical trial. It is planned to enroll patients admitted with anterior ST-segment elevation myocardial infarction (STEMI) within 6h of symptom onset and undergo primary percutaneous coronary intervention (pPCI). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Dexmedetomidine (DEX)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
9 sitesChina
Study dates
27 May 2021to Dec 2025
Phase
Interventional
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: the enrolled subjects must meet all of the following criteria:

  • Aged 18-75 years old (inclusive);
  • Diagnosed with anterior STEMI within 6h of symptom onset: (1) ischemic chest discomfort; (2) electrocardiogram (ECG) with ST elevation ≥0.2 mV in 2 or more contiguous precordial leads (one of which should be V2, V3, or V4);
  • Sign the informed consent form.

Exclusion Criteria: subjects who meet any one of the following criteria are excluded from the study:

  • Ventricular fibrillation, cardiogenic shock, Killip III-IV grade;
  • Sinus bradycardia (heart rate sustained <60 beats/min), PR interval> 240ms or II-III degree atrioventricular block;
  • Continuous systolic blood pressure <120mmHg;
  • Severe breathing difficulties, aterial blood oxygen saturation <92%;
  • Thrombolytic therapy has been performed before the first medical contact in the hospital;
  • Consciousness disorder or past cerebrovascular disease;
  • Previous history of myocardial infarction or PCI/CABG treatment;
  • Known severe liver and kidney dysfunction;
  • Known allergy to dexmedetomidine;
  • CMR contraindications: such as claustrophobia, pacemaker or ICD implantation;
  • Pregnant or lactating women;
  • Malignant tumor or expected survival time <1 year;
  • Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, poor compliance, inability of the patient to comply with study procedures and/or follow up);
  • Participate in other randomized controlled studies at the same time.

Trial locations and contacts

9 sites in 1 country.

Jiannan Dai, M.D., Ph.D contact

+86 15124559838

daijiannandr@163.com

Jinfeng Tan, M.D. contact

+86 13633643383

418904005@qq.com

9 sites in 1 country

China9 sites, 9 recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

    Jiannan Dai, 15124559838, daijiannandr@163.com

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000

    Yangjing Xie, 13721053618, xieyj2011@foxmail.com

    Recruiting

  • The First Affiliated Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Bo Zhang, 13359401106, 783846183@qq.com

    Recruiting

  • Mudanjiang Cardiovascular Hospital

    Mudanjiang, Heilongjiang, 1570011

    Wanqing Zhao, 18946326812, xingyunxing158@yeah.net

    Recruiting

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 30001

    Jingyi Liu, 18235123471, Janeyiliu@163.com

    Recruiting

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300192

    Dachuan Xia, 13902061361, xiadachuan@126.com

    Recruiting

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei, 430022

    Sheng Bi, 13971668450, bisheng_123123@163.com

    Recruiting

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

    Nier Zhong, 13201790519, zhongnier@sina.com

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

    Xiaohui Zheng, 18838910817, 16859755@qq.com

    Recruiting

Other trials in China

About this study

Official title: Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction: a Double-Blind, Multicenter, Randomized, Placebo-Controlled Clinical Trial

This is a double-blind, multicenter, randomized, placebo-controlled clinical trial. It is planned to enroll patients admitted with anterior ST-segment elevation myocardial infarction (STEMI) within 6h of symptom onset and undergo primary percutaneous coronary intervention (pPCI). Patients who meet the inclusion criteria and without exclusion criteria were randomized 1:1 into the dexmedetomidine (DEX) group or the placebo (saline) group after signing the informed consent. In the DEX group, intravenous injection of DEX was started immediately after enrollment, covering the entire PCI operation, and the administration was stopped at the end of the pPCI. The administration of saline was the same as those in the DEX group. The primary endpoint was the myocardial infarct size (MIS) as assessed by cardiac magnetic resonance imaging (CMR) at 5±2 days post-STEMI. Based on a superiority design and assuming an 20.0% relative infarct size reduction (from 26.0% to 20.8% with a SD of 13.0%), 250 patients are required to be enrolled, accounting for 20% drop-out (α= 0.05 and power= 80%).

Being tested
Dexmedetomidine (DEX), Placebo (Saline)
Keywords
ST-segment Elevation Myocardial Infarction (STEMI), Percutaneous coronary intervention, Dexmedetomidine, Cardioprotection
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.

  • Dexmedetomidine (DEX)Drug

    The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.

  • Placebo (Saline)Drug

    The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX.

Study groups in NCT04912518
Study groupRoleWhat they receive
Dexmedetomidine (DEX) groupActive comparatorThe patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.
Receives: Drug: Dexmedetomidine (DEX)
Placebo (Saline) groupPlacebo comparatorThe patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX group.
Receives: Drug: Placebo (Saline)

What is being measured

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

  1. Myocardial infarction size (MIS) evaluated by CMR 5±2 days post-STEMI.

    MIS was measured by CMR delayed gadolinium enhancement（expressed as %LV myocardial mass).

    Measured: 5±2 days post-STEMI

Secondary outcomes (7)

  1. Myocardial salvage index (MSI) evaluated by CMR 5±2 days post-STEMI.

    MSI defined as: (area at risk - myocardial infarct size) / area at risk × 100.

    Measured: 5±2 days post-STEMI

  2. Microvascular obstruction (MVO) evaluated by CMR 5±2 days post-STEMI.

    MVO was evaluated qualitatively on delayed enhanced images; it was defined as hypodense regions within the hyperenhanced infracted area.

    Measured: 5±2 days post-STEMI

  3. Left ventricular ejection fraction (LVEF) evaluated by CMR 5±2 days post-STEMI.

    LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100.

    Measured: 5±2 days post-STEMI

  4. The area under curve (AUC) for troponin I (cTnI) and creatine kinase-MB (CK-MB).

    Myocardial ischemic injury markers refer to CK-MB and cTnI

    Measured: First medical contact in hospital (before drug administration, baseline), and return to ward immediately, 6 Hours, 12 Hours, 24 Hours, 48 Hours after PCI procedure

  5. The peak value for troponin I (cTnI) and creatine kinase-MB (CK-MB).

    Myocardial ischemic injury markers refer to CK-MB and cTnI

    Measured: First medical contact in hospital (before drug administration, baseline), and return to ward immediately, 6 Hours, 12 Hours, 24 Hours, 48 Hours after PCI procedure

  6. LVEF evaluated by echocardiograhy at 30 days post-STEMI.

    LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100.

    Measured: 30 days post-STEMI

  7. Incidence of major adverse cardiovascular events (MACE): cardiac death, recurrent myocardial infarction, revascularization, rehospitalization due to heart failure.

    Clinical follow-up is performed at 30 days, 3 months, 6 months, and 12 months. Follow-up at 30 days is in the outpatient clinic, other time frame follow-up is performed by phone call and clinical charts review.

    Measured: 30 days and 12 months post-STEMI

Timeline

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

  1. First posted3 Jun 2021
  2. Study start27 May 2021
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04912518
Sponsor's protocol ID
COOPERATION
Acronym
COOPERATION
Status last verified
Oct 2024
First submitted
12 May 2021
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dai J, Xing L, Jia H, Zhu Y, Zhang S, Hu S, Lin L, Ma L, Liu H, Xu M, Ren X, Yu H, Li L, Zou Y, Zhang S, Mintz GS, Hou J, Yu B. In vivo predictors of plaque erosion in patients with ST-segment elevation myocardial infarction: a clinical, angiographical, and intravascular optical coherence tomography study. Eur Heart J. 2018 Jun 7;39(22):2077-2085. doi: 10.1093/eurheartj/ehy101.

    PubMed 29547992

  • 2. The World Bank. Toward a healthy and harmonious life in China: stemming the rising tide of non-communicable diseases. http://www.worldbank.org/content/dam/Worldbank/document/NCD_ report_en.pdf (accessed Nov 27, 2013).

  • Li J, Li X, Wang Q, Hu S, Wang Y, Masoudi FA, Spertus JA, Krumholz HM, Jiang L; China PEACE Collaborative Group. ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a retrospective analysis of hospital data. Lancet. 2015 Jan 31;385(9966):441-51. doi: 10.1016/S0140-6736(14)60921-1. Epub 2014 Jun 23.

    PubMed 24969506

  • Stone GW, Selker HP, Thiele H, Patel MR, Udelson JE, Ohman EM, Maehara A, Eitel I, Granger CB, Jenkins PL, Nichols M, Ben-Yehuda O. Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol. 2016 Apr 12;67(14):1674-83. doi: 10.1016/j.jacc.2016.01.069.

    PubMed 27056772

  • Frohlich GM, Meier P, White SK, Yellon DM, Hausenloy DJ. Myocardial reperfusion injury: looking beyond primary PCI. Eur Heart J. 2013 Jun;34(23):1714-22. doi: 10.1093/eurheartj/eht090. Epub 2013 Mar 27.

    PubMed 23536610

  • Heusch G. Myocardial ischaemia-reperfusion injury and cardioprotection in perspective. Nat Rev Cardiol. 2020 Dec;17(12):773-789. doi: 10.1038/s41569-020-0403-y. Epub 2020 Jul 3.

    PubMed 32620851

  • Hausenloy DJ, Botker HE, Engstrom T, Erlinge D, Heusch G, Ibanez B, Kloner RA, Ovize M, Yellon DM, Garcia-Dorado D. Targeting reperfusion injury in patients with ST-segment elevation myocardial infarction: trials and tribulations. Eur Heart J. 2017 Apr 1;38(13):935-941. doi: 10.1093/eurheartj/ehw145. No abstract available.

    PubMed 27118196

  • Ibanez B, Macaya C, Sanchez-Brunete V, Pizarro G, Fernandez-Friera L, Mateos A, Fernandez-Ortiz A, Garcia-Ruiz JM, Garcia-Alvarez A, Iniguez A, Jimenez-Borreguero J, Lopez-Romero P, Fernandez-Jimenez R, Goicolea J, Ruiz-Mateos B, Bastante T, Arias M, Iglesias-Vazquez JA, Rodriguez MD, Escalera N, Acebal C, Cabrera JA, Valenciano J, Perez de Prado A, Fernandez-Campos MJ, Casado I, Garcia-Rubira JC, Garcia-Prieto J, Sanz-Rosa D, Cuellas C, Hernandez-Antolin R, Albarran A, Fernandez-Vazquez F, de la Torre-Hernandez JM, Pocock S, Sanz G, Fuster V. Effect of early metoprolol on infarct size in ST-segment-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention: the Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction (METOCARD-CNIC) trial. Circulation. 2013 Oct 1;128(14):1495-503. doi: 10.1161/CIRCULATIONAHA.113.003653. Epub 2013 Sep 3.

    PubMed 24002794

  • Roolvink V, Ibanez B, Ottervanger JP, Pizarro G, van Royen N, Mateos A, Dambrink JE, Escalera N, Lipsic E, Albarran A, Fernandez-Ortiz A, Fernandez-Aviles F, Goicolea J, Botas J, Remkes W, Hernandez-Jaras V, Kedhi E, Zamorano JL, Navarro F, Alfonso F, Garcia-Lledo A, Alonso J, van Leeuwen M, Nijveldt R, Postma S, Kolkman E, Gosselink M, de Smet B, Rasoul S, Piek JJ, Fuster V, van 't Hof AWJ; EARLY-BAMI Investigators. Early Intravenous Beta-Blockers in Patients With ST-Segment Elevation Myocardial Infarction Before Primary Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016 Jun 14;67(23):2705-2715. doi: 10.1016/j.jacc.2016.03.522. Epub 2016 Apr 3.

    PubMed 27050189

  • White SK, Frohlich GM, Sado DM, Maestrini V, Fontana M, Treibel TA, Tehrani S, Flett AS, Meier P, Ariti C, Davies JR, Moon JC, Yellon DM, Hausenloy DJ. Remote ischemic conditioning reduces myocardial infarct size and edema in patients with ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):178-188. doi: 10.1016/j.jcin.2014.05.015. Epub 2014 Sep 17.

    PubMed 25240548

  • Eitel I, Stiermaier T, Rommel KP, Fuernau G, Sandri M, Mangner N, Linke A, Erbs S, Lurz P, Boudriot E, Mende M, Desch S, Schuler G, Thiele H. Cardioprotection by combined intrahospital remote ischaemic perconditioning and postconditioning in ST-elevation myocardial infarction: the randomized LIPSIA CONDITIONING trial. Eur Heart J. 2015 Nov 21;36(44):3049-57. doi: 10.1093/eurheartj/ehv463. Epub 2015 Sep 17.

    PubMed 26385956

  • Hausenloy DJ, Kharbanda RK, Moller UK, Ramlall M, Aaroe J, Butler R, Bulluck H, Clayton T, Dana A, Dodd M, Engstrom T, Evans R, Lassen JF, Christensen EF, Garcia-Ruiz JM, Gorog DA, Hjort J, Houghton RF, Ibanez B, Knight R, Lippert FK, Lonborg JT, Maeng M, Milasinovic D, More R, Nicholas JM, Jensen LO, Perkins A, Radovanovic N, Rakhit RD, Ravkilde J, Ryding AD, Schmidt MR, Riddervold IS, Sorensen HT, Stankovic G, Varma M, Webb I, Terkelsen CJ, Greenwood JP, Yellon DM, Botker HE; CONDI-2/ERIC-PPCI Investigators. Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial. Lancet. 2019 Oct 19;394(10207):1415-1424. doi: 10.1016/S0140-6736(19)32039-2. Epub 2019 Sep 6.

    PubMed 31500849

  • 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

  • Hobl EL, Stimpfl T, Ebner J, Schoergenhofer C, Derhaschnig U, Sunder-Plassmann R, Jilma-Stohlawetz P, Mannhalter C, Posch M, Jilma B. Morphine decreases clopidogrel concentrations and effects: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2014 Feb 25;63(7):630-635. doi: 10.1016/j.jacc.2013.10.068. Epub 2013 Dec 4.

    PubMed 24315907

  • Thomas MR, Morton AC, Hossain R, Chen B, Luo L, Shahari NN, Hua P, Beniston RG, Judge HM, Storey RF. Morphine delays the onset of action of prasugrel in patients with prior history of ST-elevation myocardial infarction. Thromb Haemost. 2016 Jul 4;116(1):96-102. doi: 10.1160/TH16-02-0102. Epub 2016 Apr 21.

    PubMed 27099137

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine (DEX) in people with ST-segment Elevation Myocardial Infarction (STEMI) and Percutaneous Coronary Intervention, run by Harbin Medical University at 9 sites in China.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

Contact Jiannan Dai, M.D., Ph.D (+86 15124559838, daijiannandr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial infarction size (MIS) evaluated by CMR 5±2 days post-STEMI. (time frame: 5±2 days post-STEMI). 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 NCT04912518, which also lists 39 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 15 Oct 2024.

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