Coronary Artery DiseaseSOCRATESNCT02207270
Study Of Costs Realized After Percutaneous Coronary intervenTion Employing Same Day Discharge
A study testing Same day discharge and Overnight Stay in people with Coronary Artery Disease, run by Trinity Health Michigan at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether the total costs of care associated with uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through 30-day follow up are lower among patients who are randomly assigned to same day discharge (SDD) or overnight hospital stay (ON). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Same day discharge and Overnight Stay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Aug 2014to 1 Sep 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients who undergo elective or low-risk, (i.e., in the setting of unstable angina but not non-ST segment elevation myocardial infarction) urgent PCI.
- No sociodemographic factors that would preclude SDD (prohibitive factors include no family member/friend available to remain with patient until nurse phone call the following day, no working phone, no reliable transportation, home > 60 minutes from medical infrastructure, unable to obtain/pay for medications).
- PCI procedures performed between 08/04/14 and 08/03/16.
- Short term risk of in-hospital death, transfusion or contrast-induced nephropathy during the index hospitalization at or below 1% using Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) PCI registry risk prediction models.
- No in-lab complications (prolonged angina, acute closure, no reflow, significant or untreated dissection, vessel perforation, side branch occlusion, rescue glycoprotein IIb/IIIa inhibitor use, ventricular tachycardia or fibrillation requiring cardioversion/defibrillation, tamponade, pulmonary edema, stroke or transient ischemic attack, shock).
- Contrast Volume/Calculated Creatinine Clearance ratio < 3
- No recurrent chest pain, shortness of breath, hemodynamic instability, bleeding or vascular complications during 6 hours in recovery area post-PCI
Who cannot join
- Use of rotational atherectomy
- Use of a glycoprotein IIb/IIIa inhibitor infusion post-PCI
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Saint Joseph Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory
Ypsilanti, Michigan, 48197
Saint Jospeh Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory
Ypsilanti, Michigan, 48197
About this study
Official title: A Randomized Cost Minimization Analysis Comparing Same Day Discharge With Overnight Hospital Stay Following Elective and Low Risk Urgent Percutaneous Coronary Intervention.
The purpose of this study is to determine whether the total costs of care associated with uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through 30-day follow up are lower among patients who are randomly assigned to same day discharge (SDD) or overnight hospital stay (ON).
Read the detailed description
This is a prospective randomized clinical trial of same day discharge versus overnight stay for patients undergoing uncomplicated elective or low-risk urgent PCI with uncomplicated post-PCI recovery. The outcome is total cost accrued by patients from the time of index hospital presentation through 30-day post-PCI follow-up.
Conduct of PCI procedures and provision of post-PCI care will be in accordance with routine institutional practices and will not be protocol-driven.
Consented patients will be assigned to SDD or ON stay using a block randomization schedule. Randomization will occur once the patient has completed an uncomplicated 6-hour post PCI observation period.
- Conditions
- Coronary Artery Disease
- Being tested
- Same day discharge, Overnight Stay
- Keywords
- Coronary artery disease, Costs, Cost minimization, Percutaneous coronary intervention, Risk score, Same day discharge
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same day dischargeBehavioural
Also called SOCRATES
Patients randomized to SDD will be discharged home on the day of their PCI, at least 6 hours following its completion. They will receive a follow up phone call from a study coordinator the next day and at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.
Overnight StayBehavioural
Also called Standard Care
Patients who experienced uncomplicated PCI, as well as an uncomplicated 6-hour observation period, will be randomly assigned to an overnight stay, generally considered standard or routine care. Patients randomized to overnight stay will be discharged the following morning to receive a follow up phone call at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.
| Study group | Role | What they receive |
|---|---|---|
| Same day discharge | Experimental | Patients who experienced uncomplicated PCI as well as an uncomplicated 6-hour observation period, will be randomly assigned to same day discharge. Receives: Behavioral: Same day discharge |
| Overnight stay standard care | Other | Patients who experienced uncomplicated PCI, as well as an uncomplicated 6-hour observation period, will be randomly assigned to an overnight stay, generally considered standard care. Receives: Behavioral: Overnight Stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total costs from a modified societal perspective
Costs will be determined from a modified societal perspective (physician labor, office visit and outpatient drug costs will not be included) and will be reported in 2014 dollars.
Measured: Index hospital admission to 30-days post-PCI
Secondary outcomes (3)
Total costs from a 3rd party payer perspective
Costs will be determined from a from a 3rd party payer perspective (physician labor, office visit and outpatient drug costs will also be included) and will be reported in 2014 dollars.
Measured: Index hospital admission to 30-days post-PCI
Adverse clinical outcomes
Includes death, myocardial infarction, stroke, unplanned cardiac catheterization or coronary revascularization, vascular or hemorrhagic complications.
Measured: Index hospital admission to 30-days post-PCI
Rehospitalization
Inclusive of rehospitalization for any reason.
Measured: From discharge through 30-day post-PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study start11 Aug 2014
- Primary completion1 Sep 2015
- Study completion1 Sep 2015
Why it stopped: Unable to meet projected enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trail
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Heart, PC, Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Sponsor
- Investigators
- Herbert D. Aronow, MD, MPH, Principal investigator, Michigan Heart, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207270
- Sponsor's protocol ID
- HSR-14-1479
- Other IDs
- 2033.11
- Acronym
- SOCRATES
- Status last verified
- Mar 2018
- First submitted
- 28 Jul 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Abdelaal E, Rao SV, Gilchrist IC, Bernat I, Shroff A, Caputo R, Costerousse O, Pancholy SB, Bertrand OF. Same-day discharge compared with overnight hospitalization after uncomplicated percutaneous coronary intervention: a systematic review and meta-analysis. JACC Cardiovasc Interv. 2013 Feb;6(2):99-112. doi: 10.1016/j.jcin.2012.10.008. Epub 2013 Jan 23.
PubMed 23352820Amin AP, Marso SP, Rao SV, Messenger J, Chan PS, House J, Kennedy K, Robertus K, Cohen DJ, Mahoney EM. Cost-effectiveness of targeting patients undergoing percutaneous coronary intervention for therapy with bivalirudin versus heparin monotherapy according to predicted risk of bleeding. Circ Cardiovasc Qual Outcomes. 2010 Jul;3(4):358-65. doi: 10.1161/CIRCOUTCOMES.110.957290. Epub 2010 May 20.
PubMed 20488917Antman EM, Cohen M, Bernink PJ, McCabe CH, Horacek T, Papuchis G, Mautner B, Corbalan R, Radley D, Braunwald E. The TIMI risk score for unstable angina/non-ST elevation MI: A method for prognostication and therapeutic decision making. JAMA. 2000 Aug 16;284(7):835-42. doi: 10.1001/jama.284.7.835.
PubMed 10938172Barber JA, Thompson SG. Analysis of cost data in randomized trials: an application of the non-parametric bootstrap. Stat Med. 2000 Dec 15;19(23):3219-36. doi: 10.1002/1097-0258(20001215)19:233.0.co;2-p.
PubMed 11113956Brayton KM, Patel VG, Stave C, de Lemos JA, Kumbhani DJ. Same-day discharge after percutaneous coronary intervention: a meta-analysis. J Am Coll Cardiol. 2013 Jul 23;62(4):275-85. doi: 10.1016/j.jacc.2013.03.051. Epub 2013 Apr 23.
PubMed 23623905Chambers CE, Dehmer GJ, Cox DA, Harrington RA, Babb JD, Popma JJ, Turco MA, Weiner BH, Tommaso CL; Society for Cardiovascular Angiography and Interventions. Defining the length of stay following percutaneous coronary intervention: an expert consensus document from the Society for Cardiovascular Angiography and Interventions. Endorsed by the American College of Cardiology Foundation. Catheter Cardiovasc Interv. 2009 Jun 1;73(7):847-58. doi: 10.1002/ccd.22100.
PubMed 19425053Dangas GD, Claessen BE, Mehran R, Xu K, Fahy M, Parise H, Henriques JP, Ohman EM, White HD, Stone GW. Development and validation of a stent thrombosis risk score in patients with acute coronary syndromes. JACC Cardiovasc Interv. 2012 Nov;5(11):1097-105. doi: 10.1016/j.jcin.2012.07.012.
PubMed 23174632Farooq V, van Klaveren D, Steyerberg EW, Meliga E, Vergouwe Y, Chieffo A, Kappetein AP, Colombo A, Holmes DR Jr, Mack M, Feldman T, Morice MC, Stahle E, Onuma Y, Morel MA, Garcia-Garcia HM, van Es GA, Dawkins KD, Mohr FW, Serruys PW. Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. Lancet. 2013 Feb 23;381(9867):639-50. doi: 10.1016/S0140-6736(13)60108-7.
PubMed 23439103Gilchrist IC, Rhodes DA, Zimmerman HE. A single center experience with same-day transradial-PCI patients: a contrast with published guidelines. Catheter Cardiovasc Interv. 2012 Mar 1;79(4):583-7. doi: 10.1002/ccd.23159. Epub 2011 May 13.
PubMed 21542123Glaser R, Gertz Z, Matthai WH, Wilensky RL, Weiner M, Kolansky D, Hirshfeld J Jr, Herrmann H. Patient satisfaction is comparable to early discharge versus overnight observation after elective percutaneous coronary intervention. J Invasive Cardiol. 2009 Sep;21(9):464-7.
PubMed 19726820Gurm HS, Dixon SR, Smith DE, Share D, Lalonde T, Greenbaum A, Moscucci M; BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) Registry. Renal function-based contrast dosing to define safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol. 2011 Aug 23;58(9):907-14. doi: 10.1016/j.jacc.2011.05.023.
PubMed 21851878Gurm HS, Seth M, Kooiman J, Share D. A novel tool for reliable and accurate prediction of renal complications in patients undergoing percutaneous coronary intervention. J Am Coll Cardiol. 2013 Jun 4;61(22):2242-8. doi: 10.1016/j.jacc.2013.03.026.
PubMed 23721921Heyde GS, Koch KT, de Winter RJ, Dijkgraaf MG, Klees MI, Dijksman LM, Piek JJ, Tijssen JG. Randomized trial comparing same-day discharge with overnight hospital stay after percutaneous coronary intervention: results of the Elective PCI in Outpatient Study (EPOS). Circulation. 2007 May 1;115(17):2299-306. doi: 10.1161/CIRCULATIONAHA.105.591495. Epub 2007 Apr 9.
PubMed 17420341Jabara R, Gadesam R, Pendyala L, Chronos N, Crisco LV, King SB, Chen JP. Ambulatory discharge after transradial coronary intervention: Preliminary US single-center experience (Same-day TransRadial Intervention and Discharge Evaluation, the STRIDE Study). Am Heart J. 2008 Dec;156(6):1141-6. doi: 10.1016/j.ahj.2008.07.018. Epub 2008 Oct 9.
PubMed 19033010Khatri S, Webb JG, Carere RG, Amis A, Woolcott J, Chugh S, Humphries KH. Safety and cost benefit of same-day discharge after percutaneous coronary intervention. Am J Cardiol. 2002 Aug 15;90(4):425-7. doi: 10.1016/s0002-9149(02)02504-3. No abstract available.
PubMed 12161237
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cost Minimization Analysis Comparing Same Day Discharge With Overnight Hospital Stay Following Elective and Low Risk Urgent Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT02207270
- Acronym / sponsor ID
- SOCRATES / HSR-14-1479
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Costs, Cost minimization, Percutaneous coronary intervention, Risk score, Same day discharge
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet projected enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Trinity Health MichiganUniversity, hospital or other
- Collaborators
- Michigan Heart, PC, Blue Cross Blue Shield of Michigan Foundation
- Study start
- 11 Aug 2014 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the total costs of care associated with uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through 30-day follow up are lower among patients who are randomly assigned to same day discharge (SDD) or overnight hospital stay (ON).
Detailed description
This is a prospective randomized clinical trial of same day discharge versus overnight stay for patients undergoing uncomplicated elective or low-risk urgent PCI with uncomplicated post-PCI recovery. The outcome is total cost accrued by patients from the time of index hospital presentation through 30-day post-PCI follow-up.
Conduct of PCI procedures and provision of post-PCI care will be in accordance with routine institutional practices and will not be protocol-driven.
Consented patients will be assigned to SDD or ON stay using a block randomization schedule. Randomization will occur once the patient has completed an uncomplicated 6-hour post PCI observation period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trail
| Arm | Type | Receives |
|---|---|---|
| Same day discharge | Experimental | Behavioral: Same day dischargePatients who experienced uncomplicated PCI as well as an uncomplicated 6-hour observation period, will be randomly assigned to same day discharge. |
| Overnight stay standard care | Other | Behavioral: Overnight StayPatients who experienced uncomplicated PCI, as well as an uncomplicated 6-hour observation period, will be randomly assigned to an overnight stay, generally considered standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Consecutive patients who undergo elective or low-risk, (i.e., in the setting of unstable angina but not non-ST segment elevation myocardial infarction) urgent PCI.
- No sociodemographic factors that would preclude SDD (prohibitive factors include no family member/friend available to remain with patient until nurse phone call the following day, no working phone, no reliable transportation, home > 60 minutes from medical infrastructure, unable to obtain/pay for medications).
- PCI procedures performed between 08/04/14 and 08/03/16.
- Short term risk of in-hospital death, transfusion or contrast-induced nephropathy during the index hospitalization at or below 1% using Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) PCI registry risk prediction models.
- No in-lab complications (prolonged angina, acute closure, no reflow, significant or untreated dissection, vessel perforation, side branch occlusion, rescue glycoprotein IIb/IIIa inhibitor use, ventricular tachycardia or fibrillation requiring cardioversion/defibrillation, tamponade, pulmonary edema, stroke or transient ischemic attack, shock).
Key exclusion criteria (2 listed)
- Use of rotational atherectomy
- Use of a glycoprotein IIb/IIIa inhibitor infusion post-PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same day dischargeAlso: SOCRATESPatients randomized to SDD will be discharged home on the day of their PCI, at least 6 hours following its completion. They will receive a follow up phone call from a study coordinator the next day and at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred. | Behavioural | Same day discharge |
| Overnight StayAlso: Standard CarePatients who experienced uncomplicated PCI, as well as an uncomplicated 6-hour observation period, will be randomly assigned to an overnight stay, generally considered standard or routine care. Patients randomized to overnight stay will be discharged the following morning to receive a follow up phone call at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred. | Behavioural | Overnight stay standard care |
Primary outcome
Total costs from a modified societal perspective
Time frame: Index hospital admission to 30-days post-PCI
Costs will be determined from a modified societal perspective (physician labor, office visit and outpatient drug costs will not be included) and will be reported in 2014 dollars.
3 secondary outcomes
Total costs from a 3rd party payer perspective
Time frame: Index hospital admission to 30-days post-PCI
Adverse clinical outcomes
Time frame: Index hospital admission to 30-days post-PCI
Rehospitalization
Time frame: From discharge through 30-day post-PCI
Results and safety
The study was stopped early (reason given: Unable to meet projected enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Background: PubMed 23352820Abdelaal E, Rao SV, Gilchrist IC, Bernat I, Shroff A, Caputo R, Costerousse O, Pancholy SB, Bertrand OF. Same-day discharge compared with overnight hospitalization after uncomplicated percutaneous coronary intervention: a systematic review and meta-analysis. JACC Cardiovasc Interv. 2013 Feb;6(2):99-112. doi: 10.1016/j.jcin.2012.10.008. Epub 2013 Jan 23.
- Background: PubMed 20488917Amin AP, Marso SP, Rao SV, Messenger J, Chan PS, House J, Kennedy K, Robertus K, Cohen DJ, Mahoney EM. Cost-effectiveness of targeting patients undergoing percutaneous coronary intervention for therapy with bivalirudin versus heparin monotherapy according to predicted risk of bleeding. Circ Cardiovasc Qual Outcomes. 2010 Jul;3(4):358-65. doi: 10.1161/CIRCOUTCOMES.110.957290. Epub 2010 May 20.
- Background: PubMed 10938172Antman EM, Cohen M, Bernink PJ, McCabe CH, Horacek T, Papuchis G, Mautner B, Corbalan R, Radley D, Braunwald E. The TIMI risk score for unstable angina/non-ST elevation MI: A method for prognostication and therapeutic decision making. JAMA. 2000 Aug 16;284(7):835-42. doi: 10.1001/jama.284.7.835.
- Background: PubMed 11113956Barber JA, Thompson SG. Analysis of cost data in randomized trials: an application of the non-parametric bootstrap. Stat Med. 2000 Dec 15;19(23):3219-36. doi: 10.1002/1097-0258(20001215)19:233.0.co;2-p.
- Background: PubMed 23623905Brayton KM, Patel VG, Stave C, de Lemos JA, Kumbhani DJ. Same-day discharge after percutaneous coronary intervention: a meta-analysis. J Am Coll Cardiol. 2013 Jul 23;62(4):275-85. doi: 10.1016/j.jacc.2013.03.051. Epub 2013 Apr 23.
- Background: PubMed 19425053Chambers CE, Dehmer GJ, Cox DA, Harrington RA, Babb JD, Popma JJ, Turco MA, Weiner BH, Tommaso CL; Society for Cardiovascular Angiography and Interventions. Defining the length of stay following percutaneous coronary intervention: an expert consensus document from the Society for Cardiovascular Angiography and Interventions. Endorsed by the American College of Cardiology Foundation. Catheter Cardiovasc Interv. 2009 Jun 1;73(7):847-58. doi: 10.1002/ccd.22100.
- Background: PubMed 23174632Dangas GD, Claessen BE, Mehran R, Xu K, Fahy M, Parise H, Henriques JP, Ohman EM, White HD, Stone GW. Development and validation of a stent thrombosis risk score in patients with acute coronary syndromes. JACC Cardiovasc Interv. 2012 Nov;5(11):1097-105. doi: 10.1016/j.jcin.2012.07.012.
- Background: PubMed 23439103Farooq V, van Klaveren D, Steyerberg EW, Meliga E, Vergouwe Y, Chieffo A, Kappetein AP, Colombo A, Holmes DR Jr, Mack M, Feldman T, Morice MC, Stahle E, Onuma Y, Morel MA, Garcia-Garcia HM, van Es GA, Dawkins KD, Mohr FW, Serruys PW. Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. Lancet. 2013 Feb 23;381(9867):639-50. doi: 10.1016/S0140-6736(13)60108-7.
- Background: PubMed 21542123Gilchrist IC, Rhodes DA, Zimmerman HE. A single center experience with same-day transradial-PCI patients: a contrast with published guidelines. Catheter Cardiovasc Interv. 2012 Mar 1;79(4):583-7. doi: 10.1002/ccd.23159. Epub 2011 May 13.
- Background: PubMed 19726820Glaser R, Gertz Z, Matthai WH, Wilensky RL, Weiner M, Kolansky D, Hirshfeld J Jr, Herrmann H. Patient satisfaction is comparable to early discharge versus overnight observation after elective percutaneous coronary intervention. J Invasive Cardiol. 2009 Sep;21(9):464-7.
- Background: PubMed 21851878Gurm HS, Dixon SR, Smith DE, Share D, Lalonde T, Greenbaum A, Moscucci M; BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) Registry. Renal function-based contrast dosing to define safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol. 2011 Aug 23;58(9):907-14. doi: 10.1016/j.jacc.2011.05.023.
- Background: PubMed 23721921Gurm HS, Seth M, Kooiman J, Share D. A novel tool for reliable and accurate prediction of renal complications in patients undergoing percutaneous coronary intervention. J Am Coll Cardiol. 2013 Jun 4;61(22):2242-8. doi: 10.1016/j.jacc.2013.03.026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert D. Aronow, MD, MPH principal investigator
Michigan Heart, PC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same day discharge and Overnight Stay in people with Coronary Artery Disease, run by Trinity Health Michigan at 2 sites in United States.
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 7 inclusion and 2 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: stopped early, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: Unable to meet projected enrollment). Results are not available in the source record.
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?
Total costs from a modified societal perspective (time frame: Index hospital admission to 30-days post-PCI). 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 NCT02207270, which also lists 34 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 22 Mar 2018.