Ischemic Heart DiseasePerspectiveNCT01946724
In-hospital and Long-term Outcomes for Percutaneous Chronic Total Coronary Occlusion Revascularization in a High-volume, Multi-operator Program
An observational study of Ischemic Heart Disease, run by Piedmont Healthcare at 1 site in United States.
Trial summary
The purpose of this study is to study whether percutaneous chronic total occlusion (CTO) revascularization, by the use of Percutaneous Coronary Intervention (PCI), stenting, guidewire, and catheter, improves a patient's quality of life and their left ventricular function, reduces angina severity, and improves… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 24 May 2017
- Phase
- Observational
- 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
Study population: Subjects experiencing clinical symptoms considered suggestive of ischemic heart disease or having evidence of myocardial ischemia who have had or are scheduled to have percutaneous chronic total occlusion (CTO) revasulcarization by Percutaneous Coronary Intervention (PCI)
Who may be able to join
- The subject is > 18 years of age at the time of consent
- Subjects experiencing clinical symptoms considered suggestive of ischemic heart disease (eg, chest pain or discomfort or symptoms considered by the investigator to represent anginal equivalents) or having evidence of myocardial ischemia (eg, abnormal functional study) attributed to the CTO target vessel and scheduled for clinically indicated percutaneous CTO revascularization or are subjects with multi-vessel disease and/or Acute Coronary Syndrome (ACS) that are undergoing a staged CTO PCI procedure with the intent to achieve complete revascularization.
- Subject must have at least 1 target segment meeting non-acute total coronary occlusion as defined below. A CTO is any non-acute total coronary occlusion fulfilling the following angiographic characteristics and:
- High-grade native coronary stenosis
- Thrombolysis in Myocardial Infarction (TIMI) 0 or 1 antegrade flow
- Estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram, functional study or electrocardiogram
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- CTO segment may be de novo or previously treated via PCI
- Subject is eligible and consents to undergo or has undergone a PCI procedure
- Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA) and stenting.
- Subject is willing and able to provide informed consent as approved by local Institutional Review Board/Ethics Committee and to complete the protocol requirements for the study.
- Female subjects of child-bearing potential with a negative qualitative or quantitative pregnancy test in accordance to the Piedmont Hospital Policy.
Who cannot join
- Any known allergy, hypersensitivity or contraindication to iodinated contrast that cannot be effectively managed medically
- Any known allergy, hypersensitivity or contraindication to clopidogrel bisulfate (Plavix®), prasugrel (Effient®) or ticagrelor (Brilinta®)-- for which alternative agents cannot be used-- or aspirin, heparin, nickel, stainless steel, zotarolimus, or everolimus
- Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI
- Subjects with any other pathology or indication which in the opinion of the investigator, might put the subject at risk, preclude follow-up, or in any way confound the results of the study
- Known previous medical condition yielding expected survival less than one year
- Subjects who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
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- Subjects with evidence of ongoing or active clinical instability including any of the following:
- Sustained systolic blood pressure < 100 mmHg (if different from baseline) or cardiogenic shock
- Acute pulmonary edema that has not been medically stabilized
- Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
- Suspected dissecting aortic aneurysm
- Subjects with known clinically significant abnormal laboratory findings including:
- White Blood Cells (<1,000 WBC/mm3)
- Thrombocytopenia (<100,000 platelets/mm3)
- Subjects with history of bleeding diathesis or coagulapathy or refusal of blood transfusions
- Female subjects of child-bearing potential with a positive qualitative or quantitative pregnancy test or with a negative qualitative or quantitative pregnancy test who plan to become pregnant within 12 months of enrolling in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PERSPECTIVE: Percutaneous Revascularization at Piedmont for Chronic Total Occlusions Survey
The purpose of this study is to study whether percutaneous chronic total occlusion (CTO) revascularization, by the use of Percutaneous Coronary Intervention (PCI), stenting, guidewire, and catheter, improves a patient's quality of life and their left ventricular function, reduces angina severity, and improves long-term survival.
Read the detailed description
The purpose of this study is to study whether percutaneous chronic total occlusion (CTO) revascularization, by the use of Percutaneous Coronary Intervention (PCI), stenting, guidewire, and catheter, improves a patient's quality of life and their left ventricular function, reduces angina severity, and improves long-term survival. The study will consist of the two following groups:
Retrospective patients This group will consist of consecutive patients that have already undergone CTO PCI by the PHI CTO team.
- The patients will be contacted by telephone for informed consent and will be asked how they are feeling and if they have seen any doctors for their heart conditions. The patient will also be asked if they are taking antiplatelet medicines as prescribed, and if there have been any changes in on their medicines.
- If more than 12 months have passed since the procedure, the patients will be queried regarding medical history
- If the patient cannot be contacted, then analysis of data will be limited to de-identified data collected from the chart, procedure angiogram, and the procedure report.
Prospective patients This group will consist of patients in which the CTO procedure will be performed by the PHI CTO team.
- A clinical assessment will be performed before the stent procedure
- A blood sample will be taken for routine blood chemistry and hematology
- Medications will be prescribed to prevent blood clots
- Follow-up will occur 6 and 12 months post-procedure
- Conditions
- Ischemic Heart Disease
- Medical subject headings
- Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
CTO procedural success
CTO procedural success as defined by an achievement of a final residual angiographic stenosis < 50% within the treated segment with >=TIMI 2 antegrade flow.
Measured: 1 year
Secondary outcomes (2)
Major Adverse Cardiac Events (MACE)
The occurrence of major adverse cardiac events (MACE): death, myocardial infarction, and repeat target lesion revascularization (TLR) prior to index hospitalization discharge (< 1 year from procedure)
Measured: Prior to Index Hospitalization Discharge (< 1 year from procedure)
Clinical Outcomes
Compare 1-year clinical outcomes among patients treated with zotarolimus-eluting stents with a performance goal derived from prior chronic total occlusion drug-eluting stent trials
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startAug 2013
- Primary completion24 May 2017
- Study completion24 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Kandzari, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946724
- Sponsor's protocol ID
- Perspective
- Acronym
- Perspective
- Status last verified
- Mar 2019
- First submitted
- 12 Sep 2013
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERSPECTIVE: Percutaneous Revascularization at Piedmont for Chronic Total Occlusions Survey
- ClinicalTrials.gov ID
- NCT01946724
- Acronym / sponsor ID
- Perspective / Perspective
- Conditions
- Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 20 Sep 2013 (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 study whether percutaneous chronic total occlusion (CTO) revascularization, by the use of Percutaneous Coronary Intervention (PCI), stenting, guidewire, and catheter, improves a patient's quality of life and their left ventricular function, reduces angina severity, and improves long-term survival.
Detailed description
The purpose of this study is to study whether percutaneous chronic total occlusion (CTO) revascularization, by the use of Percutaneous Coronary Intervention (PCI), stenting, guidewire, and catheter, improves a patient's quality of life and their left ventricular function, reduces angina severity, and improves long-term survival. The study will consist of the two following groups:
Retrospective patients This group will consist of consecutive patients that have already undergone CTO PCI by the PHI CTO team.
- The patients will be contacted by telephone for informed consent and will be asked how they are feeling and if they have seen any doctors for their heart conditions. The patient will also be asked if they are taking antiplatelet medicines as prescribed, and if there have been any changes in on their medicines.
- If more than 12 months have passed since the procedure, the patients will be queried regarding medical history
- If the patient cannot be contacted, then analysis of data will be limited to de-identified data collected from the chart, procedure angiogram, and the procedure report.
Prospective patients This group will consist of patients in which the CTO procedure will be performed by the PHI CTO team.
- A clinical assessment will be performed before the stent procedure
- A blood sample will be taken for routine blood chemistry and hematology
- Medications will be prescribed to prevent blood clots
- Follow-up will occur 6 and 12 months post-procedure
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects experiencing clinical symptoms considered suggestive of ischemic heart disease or having evidence of myocardial ischemia who have had or are scheduled to have percutaneous chronic total occlusion (CTO) revasulcarization by Percutaneous Coronary Intervention (PCI)
Key inclusion criteria (11 listed)
- The subject is > 18 years of age at the time of consent
- Subjects experiencing clinical symptoms considered suggestive of ischemic heart disease (eg, chest pain or discomfort or symptoms considered by the investigator to represent anginal equivalents) or having evidence of myocardial ischemia (eg, abnormal functional study) attributed to the CTO target vessel and scheduled for clinically indicated percutaneous CTO revascularization or are subjects with multi-vessel disease and/or Acute Coronary Syndrome (ACS) that are undergoing a staged CTO PCI procedure with the intent to achieve complete revascularization.
- Subject must have at least 1 target segment meeting non-acute total coronary occlusion as defined below. A CTO is any non-acute total coronary occlusion fulfilling the following angiographic characteristics and:
- Subject is eligible and consents to undergo or has undergone a PCI procedure
- Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA) and stenting.
Key exclusion criteria (16 listed)
- Any known allergy, hypersensitivity or contraindication to iodinated contrast that cannot be effectively managed medically
- Any known allergy, hypersensitivity or contraindication to clopidogrel bisulfate (Plavix®), prasugrel (Effient®) or ticagrelor (Brilinta®)-- for which alternative agents cannot be used-- or aspirin, heparin, nickel, stainless steel, zotarolimus, or everolimus
- Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI
- Subjects with any other pathology or indication which in the opinion of the investigator, might put the subject at risk, preclude follow-up, or in any way confound the results of the study
- Known previous medical condition yielding expected survival less than one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CTO procedural success
Time frame: 1 year
CTO procedural success as defined by an achievement of a final residual angiographic stenosis < 50% within the treated segment with >=TIMI 2 antegrade flow.
2 secondary outcomes
Major Adverse Cardiac Events (MACE)
Time frame: Prior to Index Hospitalization Discharge (< 1 year from procedure)
Clinical Outcomes
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
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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.
David Kandzari, MD principal investigator
Piedmont Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Piedmont Healthcare at 1 site 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 11 inclusion and 16 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: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CTO procedural success (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2019.