PROspective Multicenter Imaging Study for Evaluation of Chest Pain
- 9,649 patients presenting to emergency department with chest pain
- 45 years and older
- new or worsening chest pain suspicious for clinically significant coronary artery disease
Trial Design: Randomized, parallel assignment, open label
Intervention: coronary CT angiography, stress echo, nuclear stress test, exercise ECG
Primary Endpoint: Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization.
Sponsors: NIH, NHLBI
Quality of Life Substudy
Daniel B. Mark, MD
Primary QOL Measures:
Other QOL Measures:
PROMISE TRIAL: QUALITY OF LIFE STUDY
The PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial was the first large scale randomized trial to compare clinical outcomes from the initial use of coronary computed tomographic angiography (CTA) versus the usual care strategy of functional testing in patients with chest pain and low-intermediate coronary artery disease (CAD) risk. Comparison of quality of life outcomes from these two strategies was a major secondary objective of the PROMISE research program.
Circulation. 2016 May 24;133(21):1995-2007.
Mark DB, Anstrom KJ, Sheng S, Baloch KN, Daniels MR, Hoffmann U, Patel MR, Cooper LS, Lee KL, Douglas PS, for the PROMISE Investigators.
The Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial found that initial use of ≥64 detector-row computed tomography angiography versus standard functional testing strategies (exercise ECG, stress nuclear methods, or stress echocardiography) did not improve clinical outcomes in 10 003 stable symptomatic patients with suspected coronary artery disease requiring noninvasive testing. Symptom burden and quality of life (QOL) were major secondary outcomes).
METHODS AND RESULTS:
We prospectively collected a battery of QOL instruments in 5985 patients at baseline and 6, 12, and 24 months postrandomization. The prespecified primary QOL measures were the Duke Activity Status Index and the Seattle Angina Questionnaire frequency and QOL scales. All comparisons were made as randomized. Baseline variables were well balanced in the 2982 patients randomly assigned to computed tomography angiography testing and the 3003 patients randomly assigned to functional testing. The Duke Activity Status Index improved substantially in both groups over the first 6 months following testing, but we found no evidence for a strategy-related difference (mean difference [anatomic – functional] at 24 months of follow-up, 0.1 [95% confidence interval, -0.9 to 1.1]). Similar results were seen for the Seattle Angina Questionnaire frequency scale (mean difference at 24 months, -0.2; 95% confidence interval, -0.8 to 0.4) and QOL scale (mean difference at 24 months, -0.2; 95% confidence interval, -1.3 to 0.9). None of the secondary QOL measures showed a consistent strategy-related difference.
In symptomatic patients with suspected coronary artery disease who required noninvasive testing, symptoms and QOL improved significantly. However, a strategy of initial anatomic testing, in comparison with functional testing, did not provide an incremental benefit for QOL over 2 years of follow-up.
Genders TSS, Coles A, Hoffmann U, Patel MR, Mark DB, Lee KL, Steyerberg EW, Hunink MGM, Douglas PS; CAD Consortium and the PROMISE Investigators.
JACC Cardiovasc Imaging. 2017 Jun 9. pii: S1936-878X(17)30447-3. doi: 10.1016/j.jcmg.2017.02.020. [Epub ahead of print]
- PMID: 28624401
Lu MT, Ferencik M, Roberts RS, Lee KL, Ivanov A, Adami E, Mark DB, Jaffer FA, Leipsic JA, Douglas PS, Hoffmann U.
JACC Cardiovasc Imaging. 2017 Apr 7. pii: S1936-878X(17)30262-0. doi: 10.1016/j.jcmg.2016.11.024. [Epub ahead of print]
- PMID: 28412436
Hoffmann U, Ferencik M, Udelson JE, Picard MH, Truong QA, Patel MR, Huang M, Pencina M, Mark DB, Heitner JF, Fordyce CB, Pellikka PA, Tardif JC, Budoff M, Nahhas G, Chow B, Kosinski AS, Lee KL, Douglas PS; PROMISE Investigators.
Circulation. 2017 Jun 13;135(24):2320-2332. doi: 10.1161/CIRCULATIONAHA.116.024360. Epub 2017 Apr 7.
- PMID: 28389572
Fordyce CB, Douglas PS, Roberts RS, Hoffmann U, Al-Khalidi HR, Patel MR, Granger CB, Kostis J, Mark DB, Lee KL, Udelson JE; Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) Investigators.
JAMA Cardiol. 2017 Apr 1;2(4):400-408. doi: 10.1001/jamacardio.2016.5501.
- PMID: 28199464
Comparison of visual assessment of coronary stenosis with independent quantitative coronary angiography: Findings from the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial.
Shah R, Yow E, Jones WS, Kohl LP 3rd, Kosinski AS, Hoffmann U, Lee KL, Fordyce CB, Mark DB, Lowe A, Douglas PS, Patel MR.
Am Heart J. 2017 Feb;184:1-9. doi: 10.1016/j.ahj.2016.10.014. Epub 2016 Oct 26.
- PMID: 27892881
Mark DB, Federspiel JJ, Cowper PA, Anstrom KJ, Hoffmann U, Patel MR, Davidson-Ray L, Daniels MR, Cooper LS, Knight JD, Lee KL, Douglas PS; PROMISE Investigators.
Ann Intern Med. 2016 Jul 19;165(2):94-102. doi: 10.7326/M15-2639. Epub 2016 May 24.
- PMID: 27214597 Free PMC Article
Mark DB, Anstrom KJ, Sheng S, Baloch KN, Daniels MR, Hoffmann U, Patel MR, Cooper LS, Lee KL, Douglas PS; PROMISE Investigators.
Circulation. 2016 May 24;133(21):1995-2007. doi: 10.1161/CIRCULATIONAHA.115.020259. Epub 2016 Apr 27.
- PMID: 27143676 Free PMC Article
Hemal K, Pagidipati NJ, Coles A, Dolor RJ, Mark DB, Pellikka PA, Hoffmann U, Litwin SE, Daubert MA, Shah SH, Ariani K, Bullock-Palmer RP, Martinez B, Lee KL, Douglas PS.
JACC Cardiovasc Imaging. 2016 Apr;9(4):337-46.
- PMID: 27017234 Free PMC Article
Douglas PS, Hoffmann U, Patel MR, Mark DB, Al-Khalidi HR, Cavanaugh B, Cole J, Dolor RJ, Fordyce CB, Huang M, Khan MA, Kosinski AS, Krucoff MW, Malhotra V, Picard MH, Udelson JE, Velazquez EJ, Yow E, Cooper LS, Lee KL; PROMISE Investigators.
N Engl J Med. 2015 Apr 2;372(14):1291-300. doi: 10.1056/NEJMoa1415516. Epub 2015 Mar 14.
- PMID: 25773919 Free PMC Article
Douglas PS, Hoffmann U, Lee KL, Mark DB, Al-Khalidi HR, Anstrom K, Dolor RJ, Kosinski A, Krucoff MW, Mudrick DW, Patel MR, Picard MH, Udelson JE, Velazquez EJ, Cooper L; PROMISE investigators.
Am Heart J. 2014 Jun;167(6):796-803.e1. doi: 10.1016/j.ahj.2014.03.003. Epub 2014 Mar 18.
- PMID: 24890527 Free PMC Article