Coronary Artery DiseaseNCT02756234
Implementing Myocardial Computed Tomographic Perfusion in a Community Hospital Setting
An observational study of Coronary Artery Disease, run by Lancaster General Hospital at 1 site in United States.
Trial summary
The objective of this study is to carefully monitor all patients undergoing Computed Tomographic Perfusion (CTP) at Lancaster General Hospital for safety, and determine the efficiency of the CTP procedure in a community setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 30 Aug 2018
- 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: The study will enroll patients who have undergone a clinically indicated CCTA for suspicion of coronary artery disease and have a suspected coronary stenosis ≥50%-69% on that examination.
Who may be able to join
- Index CCTA. The patient must have a CCTA done for clinical indications within the 2 weeks prior to consent/enrollment, ordered by The Heart Group of Lancaster General Health.
- Age greater than 18 years.
- Lesion(s) requiring further testing. Upon review of the coronary CT angiogram, the interpreting physician (who was trained at the Johns Hopkins course for CTP imaging) finds at least one lesion that could benefit from further evaluation, specifically at least one stenosis of 50%-70%, or lesions with unclear stenosis severity suspected of being 50%-70%.
- Referring physician agreement. The referring physician has been contacted and agrees that the patient can be approached for consent.
- Informed consent. The patient is willing and able to provide informed consent.
Who cannot join
- CCTA complication. After an observation period of at least 20 minutes after the index CCTA, any evidence of MACE, allergy, or any other untoward clinical event that reduces CTP safety or suitability (as defined by attending physician) will exclude a patient from eligibility.
- Contraindication to regadenosen according to LGH protocol (addendum 2).
- Medical record of acute ischemia as evidenced on ECG or positive cardiac biomarkers in the interim between CCTA and CTP. Electrocardiographic evidence of acute ischemia includes acute STEMI (ST elevation equal to or greater than 1mm in two or more leads), ST segment depression and/or T wave inversion (not known to be old and thought to be evidence of ongoing ischemia). Positive cardiac biomarkers include elevated troponin, myoglobin, and/or creatinine phosphokinase MB fraction).
- History of asthma or chronic obstructive pulmonary disease requiring bronchodilators or steroid therapy within the past 3 months.
- Inability to tolerate beta blockers.
- Atrio-ventricular block (Type II-III), prolonged QT interval or sick sinus syndrome.
Show all 15Show fewer
- Renal insufficiency (creatinine ≥1.6 and/or, GFR < 60 ml/m) or renal failure requiring dialysis.
- Atrial fibrillation or other markedly irregular rhythm.
- Psychological unsuitability or extreme claustrophobia.
- Pregnancy or unknown pregnancy status.
- Clinical instability as deemed by the attending physician; including but not limited to: cardiogenic shock, hypotension (systolic blood pressure < 90 mmHg), refractory hypertension (systolic blood pressure > 180 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
- Use of Viagra or Cialis in the past 24 hours.
- Known history of allergy or adverse reactions to x-ray dye, regadenoson or aminophylline.
- Use of caffeine within the previous 12 hours (inactivates regadenoson).
- History of severe aortic stenosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lancaster General Heatlh / Penn Medicine
Lancaster, Pennsylvania, 17602
About this study
The objective of this study is to carefully monitor all patients undergoing Computed Tomographic Perfusion (CTP) at Lancaster General Hospital for safety, and determine the efficiency of the CTP procedure in a community setting.
Read the detailed description
This will be a prospective, observational study designed to include a convenience sample of all qualifying patients undergoing myocardial CTP.
The study will enroll patients who have undergone a clinically indicated CCTA for suspicion of coronary artery disease and have a suspected coronary stenosis ≥50%-69% on that examination. CCTA is a clinically indicated and standard of care procedure at Lancaster General Hospital. This pilot study will enroll a convenience sample of fifteen (15) patients at Lancaster General Hospital who satisfy all study criteria.
When a patient has a coronary CTA, physician co-investigators, all of whom are certified by the Certification Board of Cardiovascular Computed Tomography and credentialed by Johns Hopkins for CTP, will evaluate the scan for the presence of lesions that would qualify the patient for inclusion. Patients with lesions between 50% and 70% will be approached for participation in the CTP study(37). Those who agree to participate will be scheduled to have the CTP performed within thirty (30) days of the initial Coronary CTA procedure.
The CTP procedure involves infusion of a stress agent and a contrast bolus prior to image acquisition. The CTP examination will be graded using the standard 17-segment myocardial model recommended by the ACCF/AHA for nuclear myocardial perfusion and stress echocardiography, in comparison to the myocardial appearance from the baseline coronary CTA. Areas of myocardial hypo-enhancement (decreased CT signal) under hyperemic conditions (coronary vasodilation during the regadenoson infusion) indicate possible ischemia.
If a coronary stenosis is severe enough to reduce myocardial perfusion, then studies have shown that an invasive therapy that includes revascularization offers benefit to the patient. Use of CTP may allow the investigators to determine, with improved accuracy, if patients have hemodynamically significant coronary stenoses. These results will be reported to the patients' treating physicians and may be used in treatment planning.
- Conditions
- Coronary Artery Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Qualifying CTP patients | A convenience sample of all qualifying patients for CTP procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as a result of CTP procedure.
Safety will be monitored by medical personnel and recorded from observations, patient interviews and the medical record during the index hospital visit(s) for CTP, from the medical record, and outpatient office records.
Measured: Through study completion, expected 1 year.
Secondary outcomes (3)
Number of days for a subject to be scheduled and complete CTP procedure post CCTA procedure.
Days from CCTA to completed CTP procedure.
Measured: 30 days
Number of minutes it takes for CTP procedure to be completed on a subject. to complete a CTP procedure.
Time (minutes) from initiation to completion of CTP procedure.
Measured: 90 minutes
Number of minutes for a Provider to review and interpret CTP data and report out on CTP procedure.
Time (minutes) to interpret the CTP procedure.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start1 May 2016
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Toshiba America Medical Systems, Inc., Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Ron Jacob, MD, Principal investigator, Lancaster General Health / Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756234
- Sponsor's protocol ID
- 2016-9-LGH
- Status last verified
- Oct 2018
- First submitted
- 22 Apr 2016
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: An abstract reporting out on clinical study will be submitted for publication.
Publications
Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.
PubMed 19007693Hamon M, Biondi-Zoccai GG, Malagutti P, Agostoni P, Morello R, Valgimigli M, Hamon M. Diagnostic performance of multislice spiral computed tomography of coronary arteries as compared with conventional invasive coronary angiography: a meta-analysis. J Am Coll Cardiol. 2006 Nov 7;48(9):1896-910. doi: 10.1016/j.jacc.2006.08.028. Epub 2006 Sep 26.
PubMed 17084268Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008 Dec 16;52(25):2135-44. doi: 10.1016/j.jacc.2008.08.058.
PubMed 19095130Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36. doi: 10.1056/NEJMoa0806576.
PubMed 19038879Abdulla J, Asferg C, Kofoed KF. Prognostic value of absence or presence of coronary artery disease determined by 64-slice computed tomography coronary angiography a systematic review and meta-analysis. Int J Cardiovasc Imaging. 2011 Mar;27(3):413-20. doi: 10.1007/s10554-010-9652-x. Epub 2010 Jun 12.
PubMed 20549366Gallagher MJ, Ross MA, Raff GL, Goldstein JA, O'Neill WW, O'Neil B. The diagnostic accuracy of 64-slice computed tomography coronary angiography compared with stress nuclear imaging in emergency department low-risk chest pain patients. Ann Emerg Med. 2007 Feb;49(2):125-36. doi: 10.1016/j.annemergmed.2006.06.043. Epub 2006 Sep 15.
PubMed 16978738Goldstein JA, Gallagher MJ, O'Neill WW, Ross MA, O'Neil BJ, Raff GL. A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain. J Am Coll Cardiol. 2007 Feb 27;49(8):863-71. doi: 10.1016/j.jacc.2006.08.064. Epub 2007 Feb 12.
PubMed 17320744Goldstein JA, Chinnaiyan KM, Abidov A, Achenbach S, Berman DS, Hayes SW, Hoffmann U, Lesser JR, Mikati IA, O'Neil BJ, Shaw LJ, Shen MY, Valeti US, Raff GL; CT-STAT Investigators. The CT-STAT (Coronary Computed Tomographic Angiography for Systematic Triage of Acute Chest Pain Patients to Treatment) trial. J Am Coll Cardiol. 2011 Sep 27;58(14):1414-22. doi: 10.1016/j.jacc.2011.03.068.
PubMed 21939822George RT, Arbab-Zadeh A, Cerci RJ, Vavere AL, Kitagawa K, Dewey M, Rochitte CE, Arai AE, Paul N, Rybicki FJ, Lardo AC, Clouse ME, Lima JA. Diagnostic performance of combined noninvasive coronary angiography and myocardial perfusion imaging using 320-MDCT: the CT angiography and perfusion methods of the CORE320 multicenter multinational diagnostic study. AJR Am J Roentgenol. 2011 Oct;197(4):829-37. doi: 10.2214/AJR.10.5689.
PubMed 21940569Rochitte CE, George RT, Chen MY, Arbab-Zadeh A, Dewey M, Miller JM, Niinuma H, Yoshioka K, Kitagawa K, Nakamori S, Laham R, Vavere AL, Cerci RJ, Mehra VC, Nomura C, Kofoed KF, Jinzaki M, Kuribayashi S, de Roos A, Laule M, Tan SY, Hoe J, Paul N, Rybicki FJ, Brinker JA, Arai AE, Cox C, Clouse ME, Di Carli MF, Lima JA. Computed tomography angiography and perfusion to assess coronary artery stenosis causing perfusion defects by single photon emission computed tomography: the CORE320 study. Eur Heart J. 2014 May;35(17):1120-30. doi: 10.1093/eurheartj/eht488. Epub 2013 Nov 19.
PubMed 24255127
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Myocardial Computed Tomographic Perfusion in a Community Hospital Setting
- ClinicalTrials.gov ID
- NCT02756234
- Acronym / sponsor ID
- 2016-9-LGH
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Lancaster General HospitalUniversity, hospital or other
- Collaborators
- Toshiba America Medical Systems, Inc., Astellas Pharma Inc
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 29 Apr 2016 (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 objective of this study is to carefully monitor all patients undergoing Computed Tomographic Perfusion (CTP) at Lancaster General Hospital for safety, and determine the efficiency of the CTP procedure in a community setting.
Detailed description
This will be a prospective, observational study designed to include a convenience sample of all qualifying patients undergoing myocardial CTP.
The study will enroll patients who have undergone a clinically indicated CCTA for suspicion of coronary artery disease and have a suspected coronary stenosis ≥50%-69% on that examination. CCTA is a clinically indicated and standard of care procedure at Lancaster General Hospital. This pilot study will enroll a convenience sample of fifteen (15) patients at Lancaster General Hospital who satisfy all study criteria.
When a patient has a coronary CTA, physician co-investigators, all of whom are certified by the Certification Board of Cardiovascular Computed Tomography and credentialed by Johns Hopkins for CTP, will evaluate the scan for the presence of lesions that would qualify the patient for inclusion. Patients with lesions between 50% and 70% will be approached for participation in the CTP study(37). Those who agree to participate will be scheduled to have the CTP performed within thirty (30) days of the initial Coronary CTA procedure.
The CTP procedure involves infusion of a stress agent and a contrast bolus prior to image acquisition. The CTP examination will be graded using the standard 17-segment myocardial model recommended by the ACCF/AHA for nuclear myocardial perfusion and stress echocardiography, in comparison to the myocardial appearance from the baseline coronary CTA. Areas of myocardial hypo-enhancement (decreased CT signal) under hyperemic conditions (coronary vasodilation during the regadenoson infusion) indicate possible ischemia.
If a coronary stenosis is severe enough to reduce myocardial perfusion, then studies have shown that an invasive therapy that includes revascularization offers benefit to the patient. Use of CTP may allow the investigators to determine, with improved accuracy, if patients have hemodynamically significant coronary stenoses. These results will be reported to the patients' treating physicians and may be used in treatment planning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualifying CTP patients | – | –A convenience sample of all qualifying patients for CTP procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll patients who have undergone a clinically indicated CCTA for suspicion of coronary artery disease and have a suspected coronary stenosis ≥50%-69% on that examination.
Key inclusion criteria (5 listed)
- Index CCTA. The patient must have a CCTA done for clinical indications within the 2 weeks prior to consent/enrollment, ordered by The Heart Group of Lancaster General Health.
- Age greater than 18 years.
- Lesion(s) requiring further testing. Upon review of the coronary CT angiogram, the interpreting physician (who was trained at the Johns Hopkins course for CTP imaging) finds at least one lesion that could benefit from further evaluation, specifically at least one stenosis of 50%-70%, or lesions with unclear stenosis severity suspected of being 50%-70%.
- Referring physician agreement. The referring physician has been contacted and agrees that the patient can be approached for consent.
- Informed consent. The patient is willing and able to provide informed consent.
Key exclusion criteria (15 listed)
- CCTA complication. After an observation period of at least 20 minutes after the index CCTA, any evidence of MACE, allergy, or any other untoward clinical event that reduces CTP safety or suitability (as defined by attending physician) will exclude a patient from eligibility.
- Contraindication to regadenosen according to LGH protocol (addendum 2).
- Medical record of acute ischemia as evidenced on ECG or positive cardiac biomarkers in the interim between CCTA and CTP. Electrocardiographic evidence of acute ischemia includes acute STEMI (ST elevation equal to or greater than 1mm in two or more leads), ST segment depression and/or T wave inversion (not known to be old and thought to be evidence of ongoing ischemia). Positive cardiac biomarkers include elevated troponin, myoglobin, and/or creatinine phosphokinase MB fraction).
- History of asthma or chronic obstructive pulmonary disease requiring bronchodilators or steroid therapy within the past 3 months.
- Inability to tolerate beta blockers.
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
Number of participants with treatment-related adverse events as a result of CTP procedure.
Time frame: Through study completion, expected 1 year.
Safety will be monitored by medical personnel and recorded from observations, patient interviews and the medical record during the index hospital visit(s) for CTP, from the medical record, and outpatient office records.
3 secondary outcomes
Number of days for a subject to be scheduled and complete CTP procedure post CCTA procedure.
Time frame: 30 days
Number of minutes it takes for CTP procedure to be completed on a subject. to complete a CTP procedure.
Time frame: 90 minutes
Number of minutes for a Provider to review and interpret CTP data and report out on CTP procedure.
Time frame: 30 minutes
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 6 Dec 2018.
- Background: PubMed 19007693Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.
- Background: PubMed 17084268Hamon M, Biondi-Zoccai GG, Malagutti P, Agostoni P, Morello R, Valgimigli M, Hamon M. Diagnostic performance of multislice spiral computed tomography of coronary arteries as compared with conventional invasive coronary angiography: a meta-analysis. J Am Coll Cardiol. 2006 Nov 7;48(9):1896-910. doi: 10.1016/j.jacc.2006.08.028. Epub 2006 Sep 26.
- Background: PubMed 19095130Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008 Dec 16;52(25):2135-44. doi: 10.1016/j.jacc.2008.08.058.
- Background: PubMed 19038879Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36. doi: 10.1056/NEJMoa0806576.
- Background: PubMed 20549366Abdulla J, Asferg C, Kofoed KF. Prognostic value of absence or presence of coronary artery disease determined by 64-slice computed tomography coronary angiography a systematic review and meta-analysis. Int J Cardiovasc Imaging. 2011 Mar;27(3):413-20. doi: 10.1007/s10554-010-9652-x. Epub 2010 Jun 12.
- Background: PubMed 16978738Gallagher MJ, Ross MA, Raff GL, Goldstein JA, O'Neill WW, O'Neil B. The diagnostic accuracy of 64-slice computed tomography coronary angiography compared with stress nuclear imaging in emergency department low-risk chest pain patients. Ann Emerg Med. 2007 Feb;49(2):125-36. doi: 10.1016/j.annemergmed.2006.06.043. Epub 2006 Sep 15.
- Background: PubMed 17320744Goldstein JA, Gallagher MJ, O'Neill WW, Ross MA, O'Neil BJ, Raff GL. A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain. J Am Coll Cardiol. 2007 Feb 27;49(8):863-71. doi: 10.1016/j.jacc.2006.08.064. Epub 2007 Feb 12.
- Background: PubMed 21939822Goldstein JA, Chinnaiyan KM, Abidov A, Achenbach S, Berman DS, Hayes SW, Hoffmann U, Lesser JR, Mikati IA, O'Neil BJ, Shaw LJ, Shen MY, Valeti US, Raff GL; CT-STAT Investigators. The CT-STAT (Coronary Computed Tomographic Angiography for Systematic Triage of Acute Chest Pain Patients to Treatment) trial. J Am Coll Cardiol. 2011 Sep 27;58(14):1414-22. doi: 10.1016/j.jacc.2011.03.068.
- Background: PubMed 21940569George RT, Arbab-Zadeh A, Cerci RJ, Vavere AL, Kitagawa K, Dewey M, Rochitte CE, Arai AE, Paul N, Rybicki FJ, Lardo AC, Clouse ME, Lima JA. Diagnostic performance of combined noninvasive coronary angiography and myocardial perfusion imaging using 320-MDCT: the CT angiography and perfusion methods of the CORE320 multicenter multinational diagnostic study. AJR Am J Roentgenol. 2011 Oct;197(4):829-37. doi: 10.2214/AJR.10.5689.
- Background: PubMed 24255127Rochitte CE, George RT, Chen MY, Arbab-Zadeh A, Dewey M, Miller JM, Niinuma H, Yoshioka K, Kitagawa K, Nakamori S, Laham R, Vavere AL, Cerci RJ, Mehra VC, Nomura C, Kofoed KF, Jinzaki M, Kuribayashi S, de Roos A, Laule M, Tan SY, Hoe J, Paul N, Rybicki FJ, Brinker JA, Arai AE, Cox C, Clouse ME, Di Carli MF, Lima JA. Computed tomography angiography and perfusion to assess coronary artery stenosis causing perfusion defects by single photon emission computed tomography: the CORE320 study. Eur Heart J. 2014 May;35(17):1120-30. doi: 10.1093/eurheartj/eht488. Epub 2013 Nov 19.
- Individual participant dataSharing planned: Yes. An abstract reporting out on clinical study will be submitted for publication.
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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.
Ron Jacob, MD principal investigator
Lancaster General Health / Penn Medicine
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 Coronary Artery Disease, run by Lancaster General Hospital 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 5 inclusion and 15 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 6 Dec 2018. 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?
Number of participants with treatment-related adverse events as a result of CTP procedure. (time frame: Through study completion, expected 1 year.). 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 NCT02756234, which also lists 10 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 6 Dec 2018; AzTrials last refreshed its copy on 1 Nov 2026.