NCT00123617

Brief Summary

The study is designed to test the hypothesis that participation in a standard phase III group based cardiac rehabilitation programme will improve psychological morbidity, quality of life and cardiovascular risk factors, along with chest pain severity and frequency in women with cardiac syndrome X.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

July 21, 2005

Last Update Submit

April 21, 2015

Conditions

Microvascular Angina

Keywords

Chest painWomenSyndrome XCardiac rehabilitationPsychological morbidityCardiovascular risk factors

Outcome Measures

Primary Outcomes (7)

  • Anxiety

    Measured at baseline then every 8 weeks for 16 weeks

  • Depression

    Measured at baseline then every 8 weeks for 16 weeks

  • Health anxiety

    Measured at baseline then every 8 weeks for 16 weeks

  • Cardiac anxiety

    Measured at baseline then every 8 weeks for 16 weeks

  • Quality of life

    Measured at baseline then every 8 weeks for 16 weeks

  • Symptom severity

    Measured at baseline then continuously for 16 weeks

  • Symptom frequency

    Measured at baseline then continuously for 16 weeks

Secondary Outcomes (3)

  • Cardiovascular risk factors

    Measured at baseline, 8 weeks and 16 weeks.

  • Physical ability

    Baseline and at 8 weeks

  • Time to pain

    Baseline and 8 weeks

Study Arms (2)

Phase III cardiac rehabilitation

EXPERIMENTAL

Phase III group-based cardiac rehabilitation classes, weekly

Procedure: Phase III group-based cardiac rehabilitation

Monitoring

NO INTERVENTION

Normal daily living, no extra visits to study centre

Interventions

Phase III group-based cardiac rehabilitationPROCEDURE

Phase III group-based cardiac rehabilitation

Also known as: Cardiac rehab
Phase III cardiac rehabilitation

Eligibility Criteria

Age30 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • Aged 30 to 80 years
  • Postmenopausal \> 1 year since last menstrual period
  • Angiographically normal coronary arteries
  • Positive treadmill exercise test for myocardial ischemia
  • Reported angina pectoris \> 2 episodes per week
  • Diagnosis \> 6 months
  • Willing to give written informed consent

You may not qualify if:

  • History of psychiatric illness
  • History of any other chronic illness
  • Participation in another research study within the previous 60 days
  • Suffer any physical condition for which exercise is a contra-indication.
  • Unwilling to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart and Lung Institute, Imperial College London

London, SW3 6LY, United Kingdom

Location

Related Publications (31)

  • Kemp HG Jr, Vokonas PS, Cohn PF, Gorlin R. The anginal syndrome associated with normal coronary arteriograms. Report of a six year experience. Am J Med. 1973 Jun;54(6):735-42. doi: 10.1016/0002-9343(73)90060-0. No abstract available.

    PMID: 4196179BACKGROUND

  • Cannon RO 3rd, Epstein SE. "Microvascular angina" as a cause of chest pain with angiographically normal coronary arteries. Am J Cardiol. 1988 Jun 1;61(15):1338-43. doi: 10.1016/0002-9149(88)91180-0. No abstract available.

    PMID: 3287885BACKGROUND

  • Raymond C. Chest pain not always what it seems; panic disorder may be cause in some. JAMA. 1989 Feb 24;261(8):1101-2. No abstract available.

    PMID: 2915426BACKGROUND

  • Sax FL, Cannon RO 3rd, Hanson C, Epstein SE. Impaired forearm vasodilator reserve in patients with microvascular angina. Evidence of a generalized disorder of vascular function? N Engl J Med. 1987 Nov 26;317(22):1366-70. doi: 10.1056/NEJM198711263172202.

    PMID: 3683470BACKGROUND

  • Cannon RO 3rd, Bonow RO, Bacharach SL, Green MV, Rosing DR, Leon MB, Watson RM, Epstein SE. Left ventricular dysfunction in patients with angina pectoris, normal epicardial coronary arteries, and abnormal vasodilator reserve. Circulation. 1985 Feb;71(2):218-26. doi: 10.1161/01.cir.71.2.218.

    PMID: 3965167BACKGROUND

  • Opherk D, Schuler G, Wetterauer K, Manthey J, Schwarz F, Kubler W. Four-year follow-up study in patients with angina pectoris and normal coronary arteriograms ("syndrome X"). Circulation. 1989 Dec;80(6):1610-6. doi: 10.1161/01.cir.80.6.1610.

    PMID: 2598425BACKGROUND

  • Shapiro LM, Crake T, Poole-Wilson PA. Is altered cardiac sensation responsible for chest pain in patients with normal coronary arteries? Clinical observation during cardiac catheterisation. Br Med J (Clin Res Ed). 1988 Jan 16;296(6616):170-1. doi: 10.1136/bmj.296.6616.170-a. No abstract available.

    PMID: 3122985BACKGROUND

  • Dean JD, Jones CJ, Hutchison SJ, Peters JR, Henderson AH. Hyperinsulinaemia and microvascular angina ("syndrome X"). Lancet. 1991 Feb 23;337(8739):456-7.

    PMID: 1671472BACKGROUND

  • Potts SG, Bass CM. Psychological morbidity in patients with chest pain and normal or near-normal coronary arteries: a long-term follow-up study. Psychol Med. 1995 Mar;25(2):339-47. doi: 10.1017/s0033291700036242.

    PMID: 7675922BACKGROUND

  • Ruggeri A, Taruschio G, Loricchio ML, Samory G, Borghi A, Bugiardini R. [The correlation between the clinical characteristics and psychological status in syndrome X patients]. Cardiologia. 1996 Jun;41(6):551-7. Italian.

    PMID: 8766418BACKGROUND

  • Mayou R. Chest pain, palpitations and panic. J Psychosom Res. 1998 Jan;44(1):53-70. doi: 10.1016/s0022-3999(97)00209-2.

    PMID: 9483464BACKGROUND

  • Cunningham C, Brown S, Kaski JC. Effects of transcendental meditation on symptoms and electrocardiographic changes in patients with cardiac syndrome X. Am J Cardiol. 2000 Mar 1;85(5):653-5, A10. doi: 10.1016/s0002-9149(99)00828-0.

    PMID: 11078284BACKGROUND

  • Ornish D, Scherwitz LW, Doody RS, Kesten D, McLanahan SM, Brown SE, DePuey E, Sonnemaker R, Haynes C, Lester J, McAllister GK, Hall RJ, Burdine JA, Gotto AM Jr. Effects of stress management training and dietary changes in treating ischemic heart disease. JAMA. 1983 Jan 7;249(1):54-9.

    PMID: 6336794BACKGROUND

  • Luebbert K, Dahme B, Hasenbring M. The effectiveness of relaxation training in reducing treatment-related symptoms and improving emotional adjustment in acute non-surgical cancer treatment: a meta-analytical review. Psychooncology. 2001 Nov-Dec;10(6):490-502. doi: 10.1002/pon.537.

    PMID: 11747061BACKGROUND

  • Atienza F, Velasco JA, Brown S, Ridocci F, Kaski JC. Assessment of quality of life in patients with chest pain and normal coronary arteriogram (syndrome X) using a specific questionnaire. Clin Cardiol. 1999 Apr;22(4):283-90. doi: 10.1002/clc.4960220406.

    PMID: 10198738BACKGROUND

  • Sand NP, Juelsgaard P. [Syndrome X. Somatic and social prognosis of patients with angina pectoris and normal coronary arteriography]. Ugeskr Laeger. 1994 Feb 21;156(8):1131-2, 1135-6. Danish.

    PMID: 8116091BACKGROUND

  • Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation I: review of psychosocial factors. Gen Hosp Psychiatry. 2002 May-Jun;24(3):121-6. doi: 10.1016/s0163-8343(02)00178-0.

    PMID: 12062135BACKGROUND

  • Yoshida T, Kohzuki M, Yoshida K, Hiwatari M, Kamimoto M, Yamamoto C, Meguro S, Endo N, Kato A, Kanazawa M, Sato T. Physical and psychological improvements after phase II cardiac rehabilitation in patients with myocardial infarction. Nurs Health Sci. 1999 Sep;1(3):163-70. doi: 10.1046/j.1442-2018.1999.00021.x.

    PMID: 10894639BACKGROUND

  • Johnston M, Foulkes J, Johnston DW, Pollard B, Gudmundsdottir H. Impact on patients and partners of inpatient and extended cardiac counseling and rehabilitation: a controlled trial. Psychosom Med. 1999 Mar-Apr;61(2):225-33. doi: 10.1097/00006842-199903000-00015.

    PMID: 10204976BACKGROUND

  • O'Callaghan WG, Teo KK, O'Riordan J, Webb H, Dolphin T, Horgan JH. Comparative response of male and female patients with coronary artery disease to exercise rehabilitation. Eur Heart J. 1984 Aug;5(8):649-51. doi: 10.1093/oxfordjournals.eurheartj.a061721.

    PMID: 6479192BACKGROUND

  • Woloshin S, Schwartz LM, Tosteson AN, Chang CH, Wright B, Plohman J, Fisher ES. Perceived adequacy of tangible social support and health outcomes in patients with coronary artery disease. J Gen Intern Med. 1997 Oct;12(10):613-8. doi: 10.1046/j.1525-1497.1997.07121.x.

    PMID: 9346457BACKGROUND

  • Horsten M, Mittleman MA, Wamala SP, Schenck-Gustafsson K, Orth-Gomer K. Depressive symptoms and lack of social integration in relation to prognosis of CHD in middle-aged women. The Stockholm Female Coronary Risk Study. Eur Heart J. 2000 Jul;21(13):1072-80. doi: 10.1053/euhj.1999.2012.

    PMID: 10843825BACKGROUND

  • Wenger NK. Social support and coronary heart disease in women: the challenge to learn more. Eur Heart J. 1998 Nov;19(11):1603-5. No abstract available.

    PMID: 9857910BACKGROUND

  • Lindsay GM, Smith LN, Hanlon P, Wheatley DJ. The influence of general health status and social support on symptomatic outcome following coronary artery bypass grafting. Heart. 2001 Jan;85(1):80-6. doi: 10.1136/heart.85.1.80.

    PMID: 11119470BACKGROUND

  • Anderson D, Posner N. Relationship between psychosocial factors and health behaviours for women experiencing menopause. Int J Nurs Pract. 2002 Oct;8(5):265-73. doi: 10.1046/j.1440-172x.2002.00376.x.

    PMID: 12225353BACKGROUND

  • Eriksson BE, Tyni-Lenne R, Svedenhag J, Hallin R, Jensen-Urstad K, Jensen-Urstad M, Bergman K, Selven C. Physical training in Syndrome X: physical training counteracts deconditioning and pain in Syndrome X. J Am Coll Cardiol. 2000 Nov 1;36(5):1619-25. doi: 10.1016/s0735-1097(00)00931-1.

    PMID: 11079667BACKGROUND

  • Tyni-Lenne R, Stryjan S, Eriksson B, Berglund M, Sylven C. Beneficial therapeutic effects of physical training and relaxation therapy in women with coronary syndrome X. Physiother Res Int. 2002;7(1):35-43. doi: 10.1002/pri.239.

    PMID: 11992983BACKGROUND

  • Salmon P. Effects of physical exercise on anxiety, depression, and sensitivity to stress: a unifying theory. Clin Psychol Rev. 2001 Feb;21(1):33-61. doi: 10.1016/s0272-7358(99)00032-x.

    PMID: 11148895BACKGROUND

  • Ransford HE, Palisi BJ. Aerobic exercise, subjective health and psychological well-being within age and gender subgroups. Soc Sci Med. 1996 Jun;42(11):1555-9. doi: 10.1016/0277-9536(95)00252-9.

    PMID: 8771638BACKGROUND

  • Perrig-Chiello P, Perrig WJ, Ehrsam R, Staehelin HB, Krings F. The effects of resistance training on well-being and memory in elderly volunteers. Age Ageing. 1998 Jul;27(4):469-75. doi: 10.1093/ageing/27.4.469.

    PMID: 9884004BACKGROUND

  • Asbury EA, Slattery C, Grant A, Evans L, Barbir M, Collins P. Cardiac rehabilitation for the treatment of women with chest pain and normal coronary arteries. Menopause. 2008 May-Jun;15(3):454-60. doi: 10.1097/gme.0b013e31815982eb.

    PMID: 18188136RESULT

MeSH Terms

Conditions

Microvascular AnginaChest Pain

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Collins, MD FRCP

    National Heart and Lung Institute, Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Cardiology

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 25, 2005

Study Start

January 1, 2003

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

GB(1)