NCT00925834

Brief Summary

The aim of this randomized controlled pilot study was to answer the following questions:

  1. 1.Is it possible to affect the diameter of coronary arteries through a placebo injection, which is administered intracoronarily together with a standardized verbal suggestion of coronary vasodilation?
  2. 2.Is it possible to affect the diameter of coronary arteries through a pharmacologically underdosed nitroglycerine injection, which is administered intracoronarily together with a standardized verbal suggestion of coronary vasodilation?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

Enrollment Period

1 month

First QC Date

June 19, 2009

Last Update Submit

June 19, 2009

Conditions

Coronary Circulation

Keywords

Coronary angiographyPlacebo effectSuggestion

Outcome Measures

Primary Outcomes (1)

  • Stenosis Diameter (Quantitative Coronary Analysis)

    60 sec after intervention

Secondary Outcomes (5)

  • Heart rate

    immediately before and after intervention

  • Systolic blood pressure

    immediately before and after intervention

  • Diastolic blood pressure

    immediately before and after intervention

  • Chest Pain

    immediately before and after intervention

  • Subjective distress

    immediately before and after intervention

Study Arms (4)

Sodium chloride

PLACEBO COMPARATOR

Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride

Behavioral: Verbal suggestions

Sodium chloride and verbal suggestions

EXPERIMENTAL

Experimental arm "A": Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels

Behavioral: Verbal suggestions

Nitroglycerin

ACTIVE COMPARATOR

Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride

Behavioral: Verbal suggestions

Nitroglycerin and verbal suggestions

EXPERIMENTAL

Control arm "B": Open intracoronary infusion of 0.01 mg nitroglycerin in 5 ml sodium chloride plus the suggestion of a vasodilatory effect on cardiac vessels

Behavioral: Verbal suggestions

Interventions

Verbal suggestionsBEHAVIORAL

Verbal suggestions of a vasodilatory effect on cardiac vessels

NitroglycerinNitroglycerin and verbal suggestionsSodium chlorideSodium chloride and verbal suggestions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medical indication for heart catheterization
  • written informed consent

You may not qualify if:

  • acute myocardial infarction
  • acute elevation of cardiac enzymes
  • regular intake of drugs containing nitroglycerin
  • intolerance of nitroglycerin
  • hypotension
  • renal insufficiency
  • diabetes mellitus
  • hyperthyroidism
  • pregnancy
  • acute psychiatric disease
  • cognitive impairment
  • prinzmetal's angina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychosomatic Medicine, Technische Universität München

Munich, 81675, Germany

Location

Study Officials

  • Joram Ronel, M.D.

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

  • Karin Meißner, M.D.

    Ludwig-Maximilians-Universität München

    PRINCIPAL INVESTIGATOR

  • Julinda Mehilli, M.D.

    Deutsches Herzzentrum München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2009

First Posted

June 22, 2009

Study Start

July 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

June 22, 2009

Record last verified: 2009-06

Locations

DE(1)