Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients With CSFP

ST Segment Elevation Myocardial Infarction Clinical Trial

Official title:

Intracoronary Infusion of Alprostadil and Nitroglycerin With Targeted Perfusion Microcatheter in STEMI Patients With Coronary Slow Flow Phenomenon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296670
• Other study ID #: LSG1501104
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2017
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study intends to evaluate the efficacy of different medicine delivering by targeted perfusion catheter in coronary administration on coronary blood flow in STEMI patients with CSFP.

Description:

The goal of STEMI therapy is to successfully restore epicardial blood flow. PCI has been documented as being the most effective method for restoration of epicardial blood flow. However, stenting does not necessarily equate to epicardial blood flow; not every patient achieves TIMI 3 flow after successful PCI.

Currently, there are two main types of interventions to improve epicardial blood flow. One is the mechanical method, which included thrombus aspiration catheter and the distal protective devices. It has been confirmed that the mechanical method can effectively improve epicardial and myocardial perfusion in patient with part of large vessels and high burden thrombus. But for patients with small vessels and no obvious visual thrombus, the efficacy is not significant.

The other intervention is medicine which included GP IIb/IIIa receptor antagonist, adenosine, sodium nitroprusside, verapamil etc. Part of the drugs have some effect but the overall clinical efficacy is still not satisfied.

The study intends to use targeted perfusion catheter to deliver drug to the distal targeted blood vessels. TFG and cTFC are applied to evaluate the efficacy of treatment with Alprostadil or Nitroglycerin on coronary blood flow in STEMI patients with CSFP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 31, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patents with myocardial infarction who have symptom onset within 12h before randomization; ECG: =2 mm ST-segment elevation in 2 contiguous precordial leads or =1 mm ST-segment elevation in 2 contiguous extremity leads ; Corrected TIMI frame counted (cTFC) measured from the final angiographic imaging after PCI exceeding 40 frames; Signed informed consent form prior to trial participation.

Exclusion Criteria:

Coronary artery bypass surgery (CABG) history; Failed in stents implanting; Severe heart failure; Cardiogenic shock.

Related Conditions & MeSH terms

• Coronary Slow Flow Phenomenon
• Infarction
• Myocardial Infarction
• No-Reflow Phenomenon
• ST Elevation Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Intervention

Drug:
• Alprostadil
alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
• Nitroglycerin
Nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP

Locations

Country	Name	City	State
China	Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University	ShangHai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

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. Chinese. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;15:58. doi: 10.1186/1532-429X-15-58. — View Citation

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. — View Citation

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: 10.3275/6711. Epub 2009 Dec 1. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIMI Flow Grade (TFG)	TIMI Flow Grade (TFG)assesses flow in the epicardial arteries	One mins after PCI
Primary	TIMI Flow Grade (TFG)	TIMI Flow Grade (TFG)assesses flow in the epicardial arteries	One mins after intracoronary medicine infusion post-PCI
Primary	TIMI Frame Count (CTFC)	CTFC is a continuous measurement assessing flow in the epicardial arteries.	One mins after PCI
Primary	TIMI Frame Count (CTFC)	CTFC is a continuous measurement assessing flow in the epicardial arteries.	One mins after intracoronary medicine infusion post-PCI
Secondary	LVEF by echocardiography	Echocardiographic index includes LVEF	Echocardiography was performed 3-7 days after PCI