Percutaneous Coronary Intervention Clinical Trial
Official title:
Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility
NCT number | NCT05160311 |
Other study ID # | 5106 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2021 |
Est. completion date | July 1, 2024 |
The purpose of this study is to evaluate whether late recanalization in patients with ST elevation myocardial infarction (STEMI) without Viability on Cardiovascular Magnetic Resonance Image (MRI) can reduce the reverse remodeling through the reduction of the End Systolic Volume (ESV) at 6 months.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | July 1, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria 1. STEMI not reperfused between 24 hours and 28 days 2. MI-related artery with > or = 50% 3. Segmental dysfunction in the artery related to infarction. 4. Technical feasibility for PCI recanalization 5. Absence of Myocardial Viability 3.3 Exclusion criteria 1. Age > 80 years 2. < 1 year life expectancy 3. Post MI Angina 4. Clinical Instability 5. Electrical Instability 6. Previous Infarction with segment disfunction 7. New York Heart Association (NYHA) class III or IV of heart failure. 8. Previous diagnosis of congestive heart failure or cardiomyopathy 9. Severe heart valve disease 10. Absence of segmental dysfunction in the artery related to infarction 11. Coronary angiography without obstructive lesions 12. Indication of myocardial revascularization surgery 13. Opted for clinical treatment for technical reasons 14. Serum creatinine concentration greater than 2.5 mg/dl 15. Pacemaker or Implantable Cardiodefibrillator (ICD) 16. Brain Clip Carriers 17. Patients with Cochlear Implants 18. Refusal to sign the Informed Consent Form (ICF). 19. Inability to maintain outpatient follow-up for 6 months. |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Dante Pazzanese de Cardiologia | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Instituto Dante Pazzanese de Cardiologia |
Brazil,
Abbate A, Biondi-Zoccai GG, Appleton DL, Erne P, Schoenenberger AW, Lipinski MJ, Agostoni P, Sheiban I, Vetrovec GW. Survival and cardiac remodeling benefits in patients undergoing late percutaneous coronary intervention of the infarct-related artery: evidence from a meta-analysis of randomized controlled trials. J Am Coll Cardiol. 2008 Mar 4;51(9):956-64. doi: 10.1016/j.jacc.2007.11.062. Epub 2008 Feb 6. — View Citation
Allman KC, Shaw LJ, Hachamovitch R, Udelson JE. Myocardial viability testing and impact of revascularization on prognosis in patients with coronary artery disease and left ventricular dysfunction: a meta-analysis. J Am Coll Cardiol. 2002 Apr 3;39(7):1151-8. — View Citation
Bellenger NG, Yousef Z, Rajappan K, Marber MS, Pennell DJ. Infarct zone viability influences ventricular remodelling after late recanalisation of an occluded infarct related artery. Heart. 2005 Apr;91(4):478-83. — View Citation
Camici PG, Prasad SK, Rimoldi OE. Stunning, hibernation, and assessment of myocardial viability. Circulation. 2008 Jan 1;117(1):103-14. doi: 10.1161/CIRCULATIONAHA.107.702993. Review. — View Citation
Cohen M, Gensini GF, Maritz F, Gurfinkel EP, Huber K, Timerman A, Krzeminska-Pakula M, Santopinto J, Hecquet C, Vittori L; TETAMI Investigators. Prospective evaluation of clinical outcomes after acute ST-elevation myocardial infarction in patients who are ineligible for reperfusion therapy: preliminary results from the TETAMI registry and randomized trial. Circulation. 2003 Oct 21;108(16 Suppl 1):III14-21. — View Citation
Dzavik V, Beanlands DS, Davies RF, Leddy D, Marquis JF, Teo KK, Ruddy TD, Burton JR, Humen DP. Effects of late percutaneous transluminal coronary angioplasty of an occluded infarct-related coronary artery on left ventricular function in patients with a recent (< 6 weeks) Q-wave acute myocardial infarction (Total Occlusion Post-Myocardial Infarction Intervention Study [TOMIIS]--a pilot study). Am J Cardiol. 1994 May 1;73(12):856-61. — View Citation
Eagle KA, Goodman SG, Avezum A, Budaj A, Sullivan CM, López-Sendón J; GRACE Investigators. Practice variation and missed opportunities for reperfusion in ST-segment-elevation myocardial infarction: findings from the Global Registry of Acute Coronary Events (GRACE). Lancet. 2002 Feb 2;359(9304):373-7. — View Citation
Erne P, Schoenenberger AW, Burckhardt D, Zuber M, Kiowski W, Buser PT, Dubach P, Resink TJ, Pfisterer M. Effects of percutaneous coronary interventions in silent ischemia after myocardial infarction: the SWISSI II randomized controlled trial. JAMA. 2007 May 9;297(18):1985-91. — View Citation
Gerber BL, Rousseau MF, Ahn SA, le Polain de Waroux JB, Pouleur AC, Phlips T, Vancraeynest D, Pasquet A, Vanoverschelde JL. Prognostic value of myocardial viability by delayed-enhanced magnetic resonance in patients with coronary artery disease and low ejection fraction: impact of revascularization therapy. J Am Coll Cardiol. 2012 Feb 28;59(9):825-35. doi: 10.1016/j.jacc.2011.09.073. — View Citation
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. Epub 2006 Nov 14. — View Citation
Horie H, Takahashi M, Minai K, Izumi M, Takaoka A, Nozawa M, Yokohama H, Fujita T, Sakamoto T, Kito O, Okamura H, Kinoshita M. Long-term beneficial effect of late reperfusion for acute anterior myocardial infarction with percutaneous transluminal coronary angioplasty. Circulation. 1998 Dec 1;98(22):2377-82. — View Citation
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, Widimský 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. — View Citation
Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med. 2000 Nov 16;343(20):1445-53. — View Citation
Late Assessment of Thrombolytic Efficacy (LATE) study with alteplase 6-24 hours after onset of acute myocardial infarction. Lancet. 1993 Sep 25;342(8874):759-66. — View Citation
Long-term effects of intravenous thrombolysis in acute myocardial infarction: final report of the GISSI study. Gruppo Italiano per lo Studio della Streptochi-nasi nell'Infarto Miocardico (GISSI). Lancet. 1987 Oct 17;2(8564):871-4. — View Citation
O'Neill W, Timmis GC, Bourdillon PD, Lai P, Ganghadarhan V, Walton J Jr, Ramos R, Laufer N, Gordon S, Schork MA, et al. A prospective randomized clinical trial of intracoronary streptokinase versus coronary angioplasty for acute myocardial infarction. N Engl J Med. 1986 Mar 27;314(13):812-8. — View Citation
Piegas LS, Feitosa G, Mattos LA, Nicolau JC, Rossi Neto JM et al. Brazilian Society of Cardiology. IV Guideline of the Brazilian Society of Cardiology on The Treatment of Acute Myocardial Infarction with ST Segment Supradeslevel. Arq Bras Cardiol.2009;93(6 supl.2):e179-e264.
Romero J, Xue X, Gonzalez W, Garcia MJ. CMR imaging assessing viability in patients with chronic ventricular dysfunction due to coronary artery disease: a meta-analysis of prospective trials. JACC Cardiovasc Imaging. 2012 May;5(5):494-508. doi: 10.1016/j.jcmg.2012.02.009. Review. — View Citation
Sabaté M. Revascularization of the infarct-related artery: never too late to do well. J Am Coll Cardiol. 2008 Mar 4;51(9):965-7. doi: 10.1016/j.jacc.2008.01.003. Epub 2008 Feb 5. — View Citation
Selvanayagam JB, Kardos A, Francis JM, Wiesmann F, Petersen SE, Taggart DP, Neubauer S. Value of delayed-enhancement cardiovascular magnetic resonance imaging in predicting myocardial viability after surgical revascularization. Circulation. 2004 Sep 21;110(12):1535-41. Epub 2004 Sep 7. — View Citation
Silva JC, Rochitte CE, Júnior JS, Tsutsui J, Andrade J, Martinez EE, Moffa PJ, Menegheti JC, Kalil-Filho R, Ramires JF, Nicolau JC. Late coronary artery recanalization effects on left ventricular remodelling and contractility by magnetic resonance imaging. Eur Heart J. 2005 Jan;26(1):36-43. Epub 2004 Nov 29. — View Citation
STATACorp. 2019. Stata Statistical Software: Release 16.0. College Station, Texas : Stata Corporation
Udelson JE, Pearte CA, Kimmelstiel CD, Kruk M, Kufera JA, Forman SA, Teresinska A, Bychowiec B, Marin-Neto JA, Höchtl T, Cohen EA, Caramori P, Busz-Papiez B, Adlbrecht C, Sadowski ZP, Ruzyllo W, Kinan DJ, Lamas GA, Hochman JS. The Occluded Artery Trial (OAT) Viability Ancillary Study (OAT-NUC): influence of infarct zone viability on left ventricular remodeling after percutaneous coronary intervention versus optimal medical therapy alone. Am Heart J. 2011 Mar;161(3):611-21. doi: 10.1016/j.ahj.2010.11.020. — View Citation
Yousef ZR, Marber MS. The open artery hypothesis: potential mechanisms of action. Prog Cardiovasc Dis. 2000 May-Jun;42(6):419-38. Review. — View Citation
Yousef ZR, Redwood SR, Bucknall CA, Sulke AN, Marber MS. Late intervention after anterior myocardial infarction: effects on left ventricular size, function, quality of life, and exercise tolerance: results of the Open Artery Trial (TOAT Study). J Am Coll Cardiol. 2002 Sep 4;40(5):869-76. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reverse myocardial remodeling after late recanalization in patients without viability | Evaluate reverse remodeling after late recanalization in patients without viability measuring End Systolic Volume (ESV) by MRI | 6 months | |
Secondary | Assessement of Left Ventricle Ejection Fraction (LVEF) | Change in LVEF measured by MRI The degree of LVEF recovery after a MI provides important prognostic information. Patients with no recovery in LVEF after MI are at high risk of sudden cardiac arrest events and death. | 6 months | |
Secondary | Assessement of Myocardial contractility | Evaluate the change of reverse LV remodeling after late recanalization assessed by MRI. | 6 months | |
Secondary | Evaluate Quality of Life | Evaluate change from baseline in patients Quality of life using Abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire.
The WHOQOL-Bref (Field Trial Version) produces a profile with four domain scores and two individually scored items about an individual's overall perception of quality of life and health. The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. The possible raw score ranges for each domain are as follows: Physical Health=28, Psychological=24, Social Relationships=12, and Environment=32. |
6 months | |
Secondary | Acute MI Event | Incidence of Acute Myocardial Infarct. | 6 months | |
Secondary | Unplanned revascularization (Ischemia Driven and Not Ischemia Driven) | Incidence of Unplanned Myocardial revascularization (Ischemia Driven and Not Ischemia Driven) after hospital discharge | 6 months | |
Secondary | Cardiovascular Death | Incidence of Cardiovascular Death. Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). | 6 months | |
Secondary | Cardiovascular-Related Hospitalization | Incidence of New Cardiovascular related Hospitalization after discharge | 6 months | |
Secondary | Stroke Event | Incidence of Stroke Event Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Not yet recruiting |
NCT05669222 -
The FAVOR V AMI Trial
|
N/A | |
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Recruiting |
NCT05240781 -
Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk
|
N/A | |
Recruiting |
NCT03378934 -
Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention
|
Phase 4 | |
Not yet recruiting |
NCT06025071 -
Residual Inflammatory Risk-Guided colcHicine in Elderly Trial
|
Phase 4 | |
Withdrawn |
NCT04043091 -
Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction
|
N/A | |
Completed |
NCT03085823 -
The All-comers Sirolimus-coated Balloon European Registry
|
||
Completed |
NCT02837744 -
Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
|
||
Completed |
NCT02044146 -
A Pharmacodynamic Study of a Personalized Strategy for P2Y12 Inhibition Versus Ticagrelor in Reducing Ischemic and Bleeding Risk
|
Phase 2/Phase 3 | |
Completed |
NCT03131271 -
Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention
|
N/A | |
Completed |
NCT01156571 -
A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
|
Phase 3 | |
Completed |
NCT01135667 -
Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI
|
Phase 4 | |
Unknown status |
NCT00751491 -
Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI)
|
Phase 3 | |
Completed |
NCT00725868 -
Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention
|
N/A | |
Completed |
NCT03708588 -
Chewed Versus Integral Pill of Ticagrelor
|
Phase 4 | |
Completed |
NCT04163393 -
R-One Efficiency For PCI Evolution With Robotic Assistance
|
N/A | |
Recruiting |
NCT05554588 -
Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
|
N/A | |
Recruiting |
NCT06080919 -
Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI).
|
N/A | |
Recruiting |
NCT05353140 -
LAAO Versus NOAC in Patients With AF and PCI
|
N/A |