Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients Undergoing Primary PCI

NCT03252665 | Unknown Phase 4 DMC

• 1 other identifier: 16CR1012A
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The study intends to evaluate the efficacy of different medicine delivering by targed perfusion catheter incoronary administration on epicardial, myocardial perfusion and clinical outcomes in STEMI patients undergoing primary PCI.

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

STEMI; myocardial perfusion; TMPFC; Nicorandil; Alprostadil

Outcome Measures

Primary Outcomes (4)

• TIMI Myocardial Perfusion Frame Count (TMPFC)

  TMPFC is a novel method to standardize and quantify myocardial perfusion by timing the filling and washout of contrast in the myocardium using cine-angiographic frame-counting. Briefly, the first frame of TMPFC was defined as the frame that clearly demonstrated the first appearance of myocardial blush beyond the IRA (F1). The last frame of TMPFC was then defined as the frame where contrast or myocardial blush disappeared (F2). TMPFC is F2-F1 frame counts at a filming rate of 15 frames/sec, or (F2-F1)×2 frame counts at the corrected filming rate of 30 frames/sec

  One mins after PCI

• TIMI Myocardial Perfusion Frame Count (TMPFC)

  TMPFC is a novel method to standardize and quantify myocardial perfusion by timing the filling and washout of contrast in the myocardium using cine-angiographic frame-counting. Briefly, the first frame of TMPFC was defined as the frame that clearly demonstrated the first appearance of myocardial blush beyond the IRA (F1). The last frame of TMPFC was then defined as the frame where contrast or myocardial blush disappeared (F2). TMPFC is F2-F1 frame counts at a filming rate of 15 frames/sec, or (F2-F1)×2 frame counts at the corrected filming rate of 30 frames/sec

  One mins after intracoronary medicine infusion post-PCI

• TIMI Myocardial Perfusion Grade (TMPG)

  TMPG is an angiographic measure of myocardial perfusion

  One mins after PCI

• TIMI Myocardial Perfusion Grade (TMPG)

  TMPG is an angiographic measure of myocardial perfusion

  One mins after intracoronary medicine infusion post-PCI

Secondary Outcomes (9)

• ST-segment Resolution

  90 mins after PCI

• Myocardial-specific isoenzyme of creatine kinase (CK-MB) enzyme levels peri-PCI

  Within 0 to 48 hours after enrollment

• TIMI Flow Grade (TFG)

  One mins after PCI

• TIMI Flow Grade (TFG)

  One mins after intracoronary medicine infusion post-PCI

• TIMI Frame Count (CTFC)

  One mins after PCI

Other Outcomes (2)

• MACE

  in-hospital (within 14 days)

• MACE

  30 days after randomization

Study Arms (3)

alprostadil

EXPERIMENTAL

alprostadil,2ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients

Drug: Alprostadil

nicorandil

EXPERIMENTAL

nicorandil,2mg, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients

Drug: Nicorandil

nitroglycerin

PLACEBO COMPARATOR

nitroglycerin,200ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients

Drug: Nitroglycerin

Interventions

Alprostadil DRUG

alprostadil,2ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients

alprostadil

Nicorandil DRUG

Nicorandil,2mg, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients

nicorandil

Nitroglycerin DRUG

Nitroglycerin,200ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients

nitroglycerin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: over 18 or 18 years old, less than 75 years old;
• Patents with myocardial infarction who have symptom onset within 6h before randomization;
• ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
• Signed informed consent form prior to trial participation.

You may not qualify if:

• Evidence of cardiac rupture;
• ECG: new left bundle branch block;
• Thrombolysis contradictions:
• Severe complication
• Other diseases with life expectancy ≤12 months;
• Any history of Severe renal or hepatic dysfunction(hepatic failure, cirrhosis, portal hypertension and active hepatitis); Neutropenia, thrombocytopenia ; Known acute pancreatitis;
• Known acute pericarditis and/or subacute bacterial endocarditis;
• Arterial aneurysm, arterial/venous malformation and aorta dissection;
• Complex heart condition
• Cardiogenic shock(SBP \<90 mmHg after fluid infusion or SBP\<100 mmHg after vasoactive drugs);
• PCI within previous 1 month or Previous coronary-artery bypass surgery(CABG);
• Previously known multivessel coronary artery disease not suitable for revascularization;
• Hospitalisation for cardiac reason within past 48 hours;
• Not suitable for clinical trial
• Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai 10th People's Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai 6th People's Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Ruijin Hospital: collaborator

Study Sites (1)

Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University

Shanghai, China

Location

Related Publications (12)

• Ding S, Pu J, Qiao ZQ, Shan P, Song W, Du Y, Shen JY, Jin SX, Sun Y, Shen L, Lim YL, He B. TIMI myocardial perfusion frame count: a new method to assess myocardial perfusion and its predictive value for short-term prognosis. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):722-32. doi: 10.1002/ccd.22298.

  PMID: 19960517 BACKGROUND

• Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18.

  PMID: 19923168 BACKGROUND

• Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation. 2000 Jan 18;101(2):125-30. doi: 10.1161/01.cir.101.2.125.

  PMID: 10637197 BACKGROUND

• van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302.

  PMID: 9639373 BACKGROUND

• Chinese Society of Cardiology of Chinese Medical Association; Editorial Board of Chinese Journal of Cardiology. [Guideline of non-ST segment elevation acute coronary syndrome]. Zhonghua Xin Xue Guan Bing Za Zhi. 2012 May;40(5):353-67. No abstract available. Chinese.

  PMID: 22883082 BACKGROUND

• 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.

  PMID: 23806080 BACKGROUND

• Roe MT, Ohman EM, Maas AC, Christenson RH, Mahaffey KW, Granger CB, Harrington RA, Califf RM, Krucoff MW. Shifting the open-artery hypothesis downstream: the quest for optimal reperfusion. J Am Coll Cardiol. 2001 Jan;37(1):9-18. doi: 10.1016/s0735-1097(00)01101-3.

  PMID: 11153779 BACKGROUND

• Pu J, Shan P, Ding S, Qiao Z, Jiang L, Song W, Du Y, Shen J, Shen L, Jin S, He B. Gender differences in epicardial and tissue-level reperfusion in patients undergoing primary angioplasty for acute myocardial infarction. Atherosclerosis. 2011 Mar;215(1):203-8. doi: 10.1016/j.atherosclerosis.2010.11.019. Epub 2010 Nov 26.

  PMID: 21176835 BACKGROUND

• Pu J, Ding S, Shan P, Qiao Z, Song W, Du Y, Shen J, Jin S, He B. Comparison of epicardial and myocardial perfusions after primary coronary angioplasty for ST-elevation myocardial infarction in patients under and over 75 years of age. Aging Clin Exp Res. 2010 Aug;22(4):295-302. doi: 10.1007/BF03337726. Epub 2009 Dec 1.

  PMID: 20009495 BACKGROUND

• Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

  PMID: 21670242 BACKGROUND

• Shen LH, Wan F, Shen L, Ding S, Gong XR, Qiao ZQ, Du YP, Song W, Shen JY, Jin SX, Pu J, Yao TB, Jiang LS, Li WZ, Zhou GW, Liu SW, Han YL, He B. Pharmacoinvasive therapy for ST elevation myocardial infarction in China: a pilot study. J Thromb Thrombolysis. 2012 Jan;33(1):101-8. doi: 10.1007/s11239-011-0657-7.

  PMID: 22094974 BACKGROUND

• Zhang W, Dai J, Zheng X, Xu K, Yang X, Shen L, Wang X, Hao Z, Qiu X, Jiang L, Shi H, Shen L, He B. Myocardial protective effect of intracoronary administration of nicorandil and alprostadil via targeted perfusion microcatheter in patients undergoing elective percutaneous coronary intervention: A randomized controlled trial. Medicine (Baltimore). 2021 Apr 16;100(15):e25551. doi: 10.1097/MD.0000000000025551.

  PMID: 33847683 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Alprostadil; Nicorandil; Nitroglycerin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors; Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Nitro Compounds

Study Officials

• Ben He, MD,PhD

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ben He, MD,PhD

CONTACT

68383609; heben1025@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 17, 2017
• Study Start: September 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 17, 2017

Record last verified: 2017-08

Locations

CN (1)